347 Global Affairs jobs in the United States

Minimum qualifications:
+ Master's degree in Statistics, Physics, Applied mathematics, Operations Research, Economics or equivalent practical experience.
+ 4 years of experience in solving product or business problems using advanced investigative, machine learning, artificial intelligence, or statistical methods including coding (e.g., Python, R, or SQL).
+ Experience in translating business requirements into data science solutions.
Preferred qualifications:
+ 8 years of experience with applying quantitative methods to analyze structured and unstructured data, draw inferences, and answer investigative questions to anticipate and address future tests.
+ Experience in Generative AI, machine learning, Natural Language Processing (NLP), and LLMs, including feature engineering, data pipelines, and causal inference.
+ Knowledge of data structures and programming languages (e.g., Python, R, or SQL) to gather, extract, and structure data.
+ Ability to work with cross-functional teams to own the development and deployment of Generative AI and Large Language Model (LLM) solutions for business problems.
Global Affairs (GA) plays an important role in Google's priorities, including regulatory lifecycle work, external engagement with key stakeholders worldwide, efforts to ensure trustworthy products, and support of the incredible opportunities opening up in artificial intelligence and beyond. Global Affairs is composed of teams that lie at the intersection of public policy, regulation, compliance, user trust and safety, and legal.
In this role, you will help the Business Intelligence Group enable more data-motivated/predictive Global Affairs organizations. You will leverage the GA data ecosystem to drive decisions for cross-GA initiatives and boost business operations.The US base salary range for this full-time position is $166,000-$244,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. Learn more about benefits at Google ( .
+ Drive and own the development and implementation of data-motivated solutions, with large language models (LLMs) and Artificial Intelligence (AI), to address business tests in Global Affairs, including providing trusted advice to policymakers, building an industry leading regulatory and compliance system, and protecting the ability to provide quality products.
+ Work with cross-functional teams to identify and address Artificial Intelligence/Machine Learning (AI/ML) tests and opportunities, leveraging LLMs for text analysis and knowledge extraction, translating business needs into analysis and evaluation metrics, and presenting recommendations to executive management and stakeholders.
+ Stay up to date with emerging trends and best practices in data science and business analytics, with an emphasis on LLMs and application to legal, compliance, and government/regulatory text analysis.
Google is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also and If you have a need that requires accommodation, please let us know by completing our Accommodations for Applicants form:

Minimum qualifications:
+ Master's degree in Statistics, Physics, Applied mathematics, Operations Research, Economics or equivalent practical experience.
+ 4 years of experience in solving product or business problems using advanced investigative, machine learning, artificial intelligence, or statistical methods including coding (e.g., Python, R, or SQL).
+ Experience in translating business requirements into data science solutions.
Preferred qualifications:
+ 8 years of experience with applying quantitative methods to analyze structured and unstructured data, draw inferences, and answer investigative questions to anticipate and address future tests.
+ Experience in Generative AI, machine learning, Natural Language Processing (NLP), and LLMs, including feature engineering, data pipelines, and causal inference.
+ Knowledge of data structures and programming languages (e.g., Python, R, or SQL) to gather, extract, and structure data.
+ Ability to work with cross-functional teams to own the development and deployment of Generative AI and Large Language Model (LLM) solutions for business problems.
Global Affairs (GA) plays an important role in Google's priorities, including regulatory lifecycle work, external engagement with key stakeholders worldwide, efforts to ensure trustworthy products, and support of the incredible opportunities opening up in artificial intelligence and beyond. Global Affairs is composed of teams that lie at the intersection of public policy, regulation, compliance, user trust and safety, and legal.
In this role, you will help the Business Intelligence Group enable more data-motivated/predictive Global Affairs organizations. You will leverage the GA data ecosystem to drive decisions for cross-GA initiatives and boost business operations.The US base salary range for this full-time position is $166,000-$244,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. Learn more about benefits at Google ( .
+ Drive and own the development and implementation of data-motivated solutions, with large language models (LLMs) and Artificial Intelligence (AI), to address business tests in Global Affairs, including providing trusted advice to policymakers, building an industry leading regulatory and compliance system, and protecting the ability to provide quality products.
+ Work with cross-functional teams to identify and address Artificial Intelligence/Machine Learning (AI/ML) tests and opportunities, leveraging LLMs for text analysis and knowledge extraction, translating business needs into analysis and evaluation metrics, and presenting recommendations to executive management and stakeholders.
+ Stay up to date with emerging trends and best practices in data science and business analytics, with an emphasis on LLMs and application to legal, compliance, and government/regulatory text analysis.
Google is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also and If you have a need that requires accommodation, please let us know by completing our Accommodations for Applicants form:

Minimum qualifications:
+ Bachelor's degree or equivalent practical experience.
+ 5 years of experience in program or project management.
+ Experience working in legal operations, risk, or compliance.
+ Experience managing system implementations or software product launches.
Preferred qualifications:
+ 5 years of experience managing cross-functional or cross-team projects.
+ Experience with in-house legal departments, legal operations, legal operation consulting.
+ Experience in consulting.
A problem isn't truly solved until it's solved for all. That's why Googlers build products that help create opportunities for everyone, whether down the street or across the globe. As a Program Manager at Google, you'll lead complex, multi-disciplinary projects from start to finish - working with stakeholders to plan requirements, manage project schedules, identify risks, and communicate clearly with cross-functional partners across the company. Your projects will often span offices, time zones, and hemispheres. It's your job to coordinate the players and keep them up to date on progress and deadlines.
The mission of the Global Affairs team is to help people around the world by promoting responsible innovation, building trust in the potential of technology, and playing a part in shaping its future.
The US base salary range for this full-time position is $147,000-$216,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. Learn more about benefits at Google ( .
+ Perform business process, data, and technology assessments to drive solution design and planning for implementation, and collaborate with engineering/external partners to develop/document product requirements and implement first-party solutions and tools.
+ Partner with stakeholders to comprehend key business and user needs, identify strategic solutions, document business requirements, plan and prioritize objectives and success criteria by collaborating with key stakeholders.
+ Manage the life cycle of first- and third-party tech and process implementations, from definition to delivery, collaborating with stakeholders, providers, and engineering teams.
+ Guide client teams through the launch life cycle, ensuring business readiness and adoption of new solutions, and develop post-launch plans for managing updates and adapt launched technology with the business.
+ Define and monitor KPIs including user satisfaction of tool components and features, and communicate progress against client expectations to gain leadership support.
Google is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also and If you have a need that requires accommodation, please let us know by completing our Accommodations for Applicants form:

Minimum qualifications:
+ Bachelor's degree or equivalent practical experience.
+ 5 years of experience in program or project management.
+ Experience working in legal operations, risk, or compliance.
+ Experience managing system implementations or software product launches.
Preferred qualifications:
+ 5 years of experience managing cross-functional or cross-team projects.
+ Experience with in-house legal departments, legal operations, legal operation consulting.
+ Experience in consulting.
A problem isn't truly solved until it's solved for all. That's why Googlers build products that help create opportunities for everyone, whether down the street or across the globe. As a Program Manager at Google, you'll lead complex, multi-disciplinary projects from start to finish - working with stakeholders to plan requirements, manage project schedules, identify risks, and communicate clearly with cross-functional partners across the company. Your projects will often span offices, time zones, and hemispheres. It's your job to coordinate the players and keep them up to date on progress and deadlines.
The mission of the Global Affairs team is to help people around the world by promoting responsible innovation, building trust in the potential of technology, and playing a part in shaping its future.
The US base salary range for this full-time position is $147,000-$216,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. Learn more about benefits at Google ( .
+ Perform business process, data, and technology assessments to drive solution design and planning for implementation, and collaborate with engineering/external partners to develop/document product requirements and implement first-party solutions and tools.
+ Partner with stakeholders to comprehend key business and user needs, identify strategic solutions, document business requirements, plan and prioritize objectives and success criteria by collaborating with key stakeholders.
+ Manage the life cycle of first- and third-party tech and process implementations, from definition to delivery, collaborating with stakeholders, providers, and engineering teams.
+ Guide client teams through the launch life cycle, ensuring business readiness and adoption of new solutions, and develop post-launch plans for managing updates and adapt launched technology with the business.
+ Define and monitor KPIs including user satisfaction of tool components and features, and communicate progress against client expectations to gain leadership support.
Google is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also and If you have a need that requires accommodation, please let us know by completing our Accommodations for Applicants form:

Minimum qualifications:
+ Bachelor's degree or equivalent practical experience.
+ 8 years of experience in program or project management.
+ Experience managing system implementations or technology product launches.
+ Experience working in legal operations or business process consulting.
Preferred qualifications:
+ 8 years of experience managing cross-functional or cross-team projects.
+ Experience with ELM technologies such as TeamConnect, Onit/SimpleLegal, LawVu, Brightflag, or similar systems.
+ Experience integrating first and third-party technology, including related data migration.
+ Experience working with and integrating large scale Finance applications with Enterprise Legal Matters (ELM) data and systems to enable single source of truth spend reporting.
+ Experience in helping teams measure and improve operational excellence, product excellence, and accessibility.
+ Understanding of ELM software, legal technology trends, with an ability to translate business needs into technical requirements.
A problem isn't truly solved until it's solved for all. That's why Googlers build products that help create opportunities for everyone, whether down the street or across the globe. As a Program Manager at Google, you'll lead complex, multi-disciplinary projects from start to finish - working with stakeholders to plan requirements, manage project schedules, identify risks, and communicate clearly with cross-functional partners across the company. Your projects will often span offices, time zones, and hemispheres. It's your job to coordinate the players and keep them up to date on progress and deadlines.
Our Global Affairs Strategy and Operations (Strat Operations) team is seeking an experienced Enterprise Legal Management (ELM) Lead to drive efficiency, innovation, and strategic impact within our legal teams' operations. In this role, you will be instrumental in evaluating and implementing systems and processes used by legal and supporting teams to manage matters, including resourcing, executing, and managing spend of the matter.The US base salary range for this full-time position is $174,000-$258,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. Learn more about benefits at Google ( .
+ Develop and execute a comprehensive ELM strategy that aligns with the Global Affairs team's objectives and the broader organizational goals.
+ Serve as a convening function to navigate complex stakeholder landscapes to align various, and often engaging priorities.
+ Lead the selection, implementation, and ongoing optimization of ELM platforms and related technologies (e.g., matter management, billing, workflow automation, etc) with consideration of first-party in-house built solutions vs third-party market available solutions.
+ Identify opportunities to leverage technology including use of AI and implement process improvements to enhance legal service delivery internally and externally.
+ Collaborate closely with business stakeholders to understand their needs, document requirements, and partner with Product and Engineering teams to execute.
Google is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also and If you have a need that requires accommodation, please let us know by completing our Accommodations for Applicants form:

Minimum qualifications:
+ Bachelor's degree or equivalent practical experience.
+ 8 years of experience in program or project management.
+ Experience managing system implementations or technology product launches.
+ Experience working in legal operations or business process consulting.
Preferred qualifications:
+ 8 years of experience managing cross-functional or cross-team projects.
+ Experience with ELM technologies such as TeamConnect, Onit/SimpleLegal, LawVu, Brightflag, or similar systems.
+ Experience integrating first and third-party technology, including related data migration.
+ Experience working with and integrating large scale Finance applications with Enterprise Legal Matters (ELM) data and systems to enable single source of truth spend reporting.
+ Experience in helping teams measure and improve operational excellence, product excellence, and accessibility.
+ Understanding of ELM software, legal technology trends, with an ability to translate business needs into technical requirements.
A problem isn't truly solved until it's solved for all. That's why Googlers build products that help create opportunities for everyone, whether down the street or across the globe. As a Program Manager at Google, you'll lead complex, multi-disciplinary projects from start to finish - working with stakeholders to plan requirements, manage project schedules, identify risks, and communicate clearly with cross-functional partners across the company. Your projects will often span offices, time zones, and hemispheres. It's your job to coordinate the players and keep them up to date on progress and deadlines.
Our Global Affairs Strategy and Operations (Strat Operations) team is seeking an experienced Enterprise Legal Management (ELM) Lead to drive efficiency, innovation, and strategic impact within our legal teams' operations. In this role, you will be instrumental in evaluating and implementing systems and processes used by legal and supporting teams to manage matters, including resourcing, executing, and managing spend of the matter.The US base salary range for this full-time position is $174,000-$258,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. Learn more about benefits at Google ( .
+ Develop and execute a comprehensive ELM strategy that aligns with the Global Affairs team's objectives and the broader organizational goals.
+ Serve as a convening function to navigate complex stakeholder landscapes to align various, and often engaging priorities.
+ Lead the selection, implementation, and ongoing optimization of ELM platforms and related technologies (e.g., matter management, billing, workflow automation, etc) with consideration of first-party in-house built solutions vs third-party market available solutions.
+ Identify opportunities to leverage technology including use of AI and implement process improvements to enhance legal service delivery internally and externally.
+ Collaborate closely with business stakeholders to understand their needs, document requirements, and partner with Product and Engineering teams to execute.
Google is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also and If you have a need that requires accommodation, please let us know by completing our Accommodations for Applicants form:

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
We are seeking a Director within Phase 4 Research in Liver, Inflammation, Respiratory Viruses, and Established Products (LIVE) to join our Global Medical Affairs team. This role is responsible for leading the Phase 4 research strategy and execution for LIVE including leading and supporting Gilead Sponsored and Collaborative studies, and serving as the Team Lead for the LIVE Integrated Evidence Plan (IEP) Execution Team (ET). The ideal candidate will have previous experience in clinical and operational research, and significant knowledge in one or more of the therapeutic areas included in LIVE.
This position is based at Gilead's Foster City, CA location.
**Specific Job Responsibilities**
+ Lead development of the Medical Affairs Research - LIVE strategic approach for data generation in alignment with LIVE Integrated Evidence Plans.
+ Lead x-functional Execution Teams and facilitate the development of the LIVE data generation plans and activities in line with the IEP
+ Lead/co-LEAD and/or contribute to the development of the IEPs across LIVE TAs
+ Support the development and execution of, and represent MAR in, cross-functional data generation working groups for LIVE.
+ Lead Gilead sponsored and collaborative research activities focused on the generation, interpretation, and communication of Real-World Data and Evidence and Clinical Outcomes Assessment (COA), including retrospective database analyses, prospective cohort studies, Patient Reported Outcomes (PRO) and implementation science studies.
+ Provide high quality technical and methodological support to cross-functional teams to effectively use RW and COA data to optimize treatment practice and improve patient outcomes throughout the lifecycle of our medicines.
+ Lead the development of communications (e.g., manuscripts, scientific forum presentations, slide decks) to build the peer reviewed published scientific evidence base.
+ Maintain and continue to enhance knowledge of technical and methodological advances and trends to ensure best approaches are used in relevant studies and evaluations.
+ Engage key clinical, methodologic, and TA experts and facilitate the building of relationships via collaboration on various projects. Provide support at advisory boards, regional educational programs, conferences and other external meetings.
+ Advise on the development, deployment, and appropriate use of Medical Scientists field tools and resources (e.g. slide decks) and ensure correct interpretation and relevant messaging in these tools.
+ Lead and support workshops and seminars to increase research capacity and literacy among MA and medical scientists and cross-functional stakeholders
+ Provide administrative support in terms of coordination for project contracting and management.
+ Adhere to all applicable pharmaceutical codes, Office of Inspector General (OIG) guidelines, and Gilead policies
+ Exhibit Gilead's core values: integrity, teamwork, accountability, excellence, and inclusion
**Educational and other Requirements:**
+ Professional degree (eg, PhD, PharmD) with 8-plus years' experience (or 4+ years with an MD) in clinical or observational research including research operations; OR master's degree (eg, MS, MPH) with 10-plus years of experience
+ Must be fully cognizant of and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials
+ Scientific knowledge/ experience in one of more of the specific TAs covered by LIVE
+ Proven track-record in developing scientific abstracts and in published peer-reviewed manuscripts
+ Demonstrated project management and organization skills including process improvement, management of multiple resources and priority projects with tight timelines while maintaining attention to detail
+ Ability to work in a global environment which may require participation in meetings outside of standard work hours to accommodate time zone differences
+ Ability to apply logic and problem-solving skills under pressure, adapt to change, and successfully work independently and within the context of a team
+ Affinity for a collaborative, team-oriented environment, and approach; must be able to appropriately interact within MA and across Development, senior management, and external customers/vendors
+ Excellent interpersonal, written, and verbal communication skills
+ Proven track record of executing clearly defined goals and objectives in a fast-paced environment
+ Self-motivated to work independently and having a positive attitude while working as part of teams
+ Ability to engage and manage multiple stakeholders to achieve the objective
**Preferred Qualifications:**
+ Pharmaceutical industry experience in Phase 4 research
The salary range for this position is:
Bay Area: $243,100.00 - $14,600.00.
Other US Locations: 221,000.00 - 286,000.00.
Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' ( poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ( RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION ( environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Position Summary

Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.

J ob Responsibilities

• Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).

• Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products.

• Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed.

• Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.

• Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines.

• Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.

• Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities.

• Serves as the sponsor point of contact to the health authority.

• Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues.

• Effectively manages and directs internal support staff and external consultants for assigned projects.

• Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions.

• Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output.

• Assess and develop innovative ideas to move GRA department to address current and future challenges.

K nowledge, Skills, and Competencies

K nowledge

• Experience working in the pharmaceutical and/or healthcare industry.

• Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA).

• RAC certification a plus.

Skills

• Strong oral and written communication skills.

• Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc.

• Able to successfully interpret and apply regulatory intelligence to work output.

• Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed.

• Able to establish close communications and working relationship with cross functional teams to meet business objectives.

Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow.

• Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS).

Competencies

See OPDC Competencies Chart (Level X)

P hysical Demands and Work Environment

Travel (approximately 20%)

See document Physical Demands and Work environment for further requirements.

Education and Related Experience

Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable.

Competencies

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development - Play an active role in professional development as a business imperative.

Minimum $146,955.00 - Maximum $210,100.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company benefits : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; .

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request ( ) .

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website .

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: . If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Position Summary

Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.

J ob Responsibilities

• Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).

• Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products.

• Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed.

• Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.

• Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines.

• Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.

• Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities.

• Serves as the sponsor point of contact to the health authority.

• Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues.

• Effectively manages and directs internal support staff and external consultants for assigned projects.

• Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions.

• Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output.

• Assess and develop innovative ideas to move GRA department to address current and future challenges.

K nowledge, Skills, and Competencies

K nowledge

• Experience working in the pharmaceutical and/or healthcare industry.

• Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA).

• RAC certification a plus.

Skills

• Strong oral and written communication skills.

• Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc.

• Able to successfully interpret and apply regulatory intelligence to work output.

• Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed.

• Able to establish close communications and working relationship with cross functional teams to meet business objectives.

Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow.

• Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS).

Competencies

See OPDC Competencies Chart (Level X)

P hysical Demands and Work Environment

Travel (approximately 20%)

See document Physical Demands and Work environment for further requirements.

Education and Related Experience

Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable.

Competencies

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development - Play an active role in professional development as a business imperative.

Minimum $146,955.00 - Maximum $210,100.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company benefits : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; .

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request ( ) .

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website .

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: . If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.