2,225 Regulatory jobs in the United States

Overview

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director Regulatory Affairs . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position may train/mentor junior staff. This position works with a high level of autonomy and requires limited coaching and mentoring.

• Manage and Develop Talent
  • May train/mentor junior staff
• Phases I-IV Research & Development Activities
  • As a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)
  • As a part of the Global Regulatory Team (GRT), lead regulatory activities for assigned project(s) in line with the global registration strategy of the product
  • Competently represents GRA on project team meetings
  • Leads and coordinates project team members in developing strategy for applicable documents/activities
  • Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission
  • Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines
  • Leads documentation of regulatory authority interactions including decisions and outcomes
  • Provides updates at the Global Regulatory Team meetings and project teams as needed
  • Collaborates effectively with regulatory operations leader (ROL)
  • Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing
  • Reviews nonclinical, clinical and CMC documentation and contributes to content as needed
  • Advises team members of major regulatory issues and provides possible solutions and leads the mitigation strategy
  • Leads and coordinates local project team members in developing strategy for applicable documents/activities
  • Ensures the quality and content of all submissions to Health Authorities
  • Leads the regional health authority meetings, liaison with local Health Authority
  • Document owner of briefing book documentation to Health Authorities
  • Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals and current regulatory guidance
  • Accountable for developing and maintaining the development core data sheet (DCDS) if required
  • Ensure compliance with global regulatory requirements and adherence to internal policies and processes
  • Provide strategic review of dossier summaries, expert statements, and development management plans
  • Provide updates to the GRT, project teams, and governance boards as needed
  • Leads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions
  • May be responsible for creating and reviewing SOPs and regulatory department operating procedures

• Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required
• Unquestionable ethics, professional integrity, and personal values consistent with SMPA values
• Ability to work in a diverse environment
• Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization
• Demonstrated ability to facilitate appropriate team decisions
• Sense of urgency and perseverance to achieve results
• Experience contributing to electronic regulatory submissions and working with regulatory templates
• Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development
• Experience reviewing nonclinical, clinical and CMC documentation and contribute to content as needed
• Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action
• Proven success/major involvement in NDA/MAA/CTD submissions and approval
• Capable of effectively negotiating with others while maintaining composure
• Development and preparation of successful regulatory strategies
• Ability to learn new therapeutic areas when necessary
• Prior history with post-marketing/brand optimization strategies and commercial awareness
• Experience interacting with the FDA and ex-US Health Authorities
• Experience in leading teams and providing leadership in Health Authority negotiations and meetings
• Ability to make complex decisions and defend difficult positions
• Comfortable presenting to all levels of the organization including Senior Management
• High degree of organizational awareness and understanding of interdependencies

• Bachelor’s degree in a related field required.
• 8 – 12 years with Master’s of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs.
• Master’s degree required (preferably in a scientific discipline)

The base salary range for this role is $187,520 to $234,400. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the highest ethical standards.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

SMPA is an Equal Employment Opportunity (EEO) employer.

Sumitomo Pharma America and Sumitomo Pharma Co., Ltd. are global pharmaceutical companies with operations across multiple regions, committed to patient needs in oncology, urology, women’s health, rare diseases, psychiatry & neurology, and cell & gene therapies. For more information, employees can contact accessibility support if needed during the application process. This description reflects current requirements and may be subject to change.

Overview

We are seeking a motivated Regulatory Affairs professional to join our team and help advance the clinical development of oncology products at ORIC. In this role, you will collaborate closely with colleagues across regulatory operations, quality, CMC, nonclinical and clinical functions to support high-quality, timely regulatory submissions. The ideal candidate is a proactive team player who thrives in cross-functional environments, communicates effectively, and can balance strategic thinking with strong execution.

1. Support regulatory submissions and contribute to strategic planning for assigned programs.
2. Prepare and deliver high-quality and timely regulatory submissions in compliance with applicable regulatory requirements.
3. Responsible for the creation, assembly, review, and archival of complex regulatory submissions which require interaction with internal and CRO teams to ensure optimal execution.
4. Develop, manage and track regulatory submission timelines.
5. Collaborate cross-functionally with regulatory operations, quality, CMC, nonclinical, clinical teams.
6. Ensure submissions meet standards for accuracy, completeness, and consistency, and maintain health authority correspondence archives.
7. Review investigator packages and support site start-up activities from regulatory perspective.
8. Expand knowledge by analyzing current regulatory issues, guidance, initiatives and effectively communicate regulatory intelligence internally.
9. Contribute to the development and review of standard operating procedures to ensure regulatory compliance.

Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

• Bachelor’s degree in a scientific or related field, advanced degree preferred.
• At least 4-5 years of regulatory affairs experience in the pharmaceutical or biotechnology industry or a combination of an advanced degree and regulatory experience.
• Experience in preparing regulatory submissions (eg, IND, DSUR, CTA, FDA meeting requests).
• Strong communication, interpersonal, and collaboration skills across internal and external stakeholders.
• Good project management skills; able to manage multiple projects simultaneously and meet deadlines.
• High attention to detail, with excellent problem-solving and analytical thinking abilities.
• Excellent writing and editorial skills, with the ability to develop high-quality clinical-regulatory documents (eg, investigator brochures, briefing documents, IND amendments, Fast Track/ODD designation requests).
• A strong scientific background with the ability to quickly acquire knowledge in the therapeutic areas and the evolving regulatory landscape.
• Familiarity with global regulatory requirements and guidelines (FDA, ICH), with the ability to gather and analyze latest regulatory intelligence and motivated to learn new things.
• Computer expertise, including Microsoft Office Suite proficiency (eg, Word, Excel, PowerPoint). Experience with regulatory information management system (Veeva RIM) is a plus.

The anticipated salary range for candidates is between $145,000-$165,000 in San Diego. The final rate offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.

ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristic.

Overview

Regulatory Affairs Consultant role at Katalyst CRO. The position involves developing global regulatory strategies for medical device products, collaborating across a matrixed organization to ensure successful global product registrations, and providing regulatory leadership across the product lifecycle.

• Develop global regulatory strategies for medical device products to meet business objectives and collaborate across a matrixed organization to ensure global success of product registrations.
• Participate on product development teams, providing regulatory strategies, timelines, and direction. Review and approve technical documentation.
• Negotiate with regulatory authorities to resolve questions or issues that arise during the product lifecycle.
• Drive product change assessments and define regulatory impact of product changes in global markets.
• Review and approve labeling, training, promotional, and advertising material.
• Maintain Regulatory Affairs product files and ensure compliance with regulatory requirements.
• Participate on audit and field action teams and support other post-market activities.
• Facilitate and prepare U.S. regulatory Pre-Submission documents and pre-submission meetings.
• Regulatory expert support for IVDR teams; implement regulatory strategies for IVDR activities; collaborate with regulatory staff from other units and agencies to develop harmonized policies, procedures, and work instructions for IVDR compliance.
• Prepare documents vital for new product market clearance, approval, and lifecycle management (including 510(k)s, PMAs/De Novo, and CE marking technical files).
• Support global regulatory registration representatives for product global registration activities.
• Keep abreast of new or revised regulations, guidelines, inspection reports, journals, meetings, etc.
• Conduct trainings and communicate materials to enhance the team's knowledge of working in a regulated environment.
• Assist Regulatory department in updating, improving, and creating internal policies and procedures.
• Participate in business meetings with external partners as needed.
• Participate in inspections/audits by notified bodies or other international regulatory bodies by producing requested documents or answering inquiries for information.

• Minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.
• Minimum 5 years of IVD Regulatory Affairs experience, including 510(k), De Novo, PMA, PMA supplement submissions.
• Experience as the RA representative on project core teams providing active regulatory guidance and RA strategies.
• Excellent knowledge of U.S. and European/International regulations and standards.
• RAPS Regulatory Affairs Certification (RAC).
• Experience interacting with FDA and/or other regulatory agencies.
• Experience reviewing design specifications and other technical documents.
• Previous experience in EU MDD/IVDD or MDR/IVDR.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

• Associate

• Contract

• Legal

• Pharmaceutical Manufacturing

Overview

Vice President / Senior Vice President - Regulatory Affairs
U.S. - Remote or Hybrid (Bay Area) | Full-time
Salary Range: $380,000 - $430,000 + Bonus + Equity

Lead the regulatory strategy behind a new era of precision medicine. This is a rare opportunity to join a clinical-stage biotech company that's redefining how rare and genetic diseases are treated. As VP/SVP of Regulatory Affairs, you'll be the architect of global regulatory strategy—guiding breakthrough therapies from development to approval and beyond. If you're ready to lead with purpose and build something transformative, this is the move worth making.

• Strategic Ownership : You'll lead all aspects of regulatory strategy across a growing pipeline of high-impact programs.
• Executive Visibility : Work directly with the C-suite and Board to shape development timelines, regulatory positioning, and global launch readiness.
• Patient-Centered Mission : Your leadership will accelerate access to therapies for underserved populations with urgent medical needs.
• Global Reach : Influence regulatory pathways across the U.S., EU, and other key markets.

• 15+ years in Regulatory Affairs, with deep experience in clinical-stage biotech
• Proven success leading INDs, CTAs, BLAs/MAAs, and global regulatory interactions
• Strong leadership and communication skills, with the ability to influence internal and external stakeholders
• Experience building and scaling regulatory teams and infrastructure
• A strategic mindset and passion for solving complex regulatory challenges

• Develop and execute global regulatory strategies across multiple therapeutic programs
• Serve as the primary liaison with health authorities, leading key interactions and submissions
• Build and mentor a high-performing regulatory team
• Partner cross-functionally to align regulatory strategy with clinical, CMC, and commercial goals
• Monitor evolving regulatory landscapes and proactively adapt strategy

• Executive Leadership : A seat at the table where your voice shapes company direction and patient impact.
• Competitive Compensation : Strong base salary, performance bonus, and meaningful equity participation.
• Comprehensive Benefits : Health coverage, 401(k) match, stock purchase plan, generous PTO, paid parental leave, and more.
• Mission-Driven Culture : Join a team united by a shared purpose—delivering transformative therapies to patients who need them most.

Overview

Join to apply for the Regulatory Affairs Manager role at Katalyst CRO .

Location: Bellevue, WA. Compensation information provided in the original listing.

• Support and advise cross-functional teams and communicate APAC regulatory requirements and challenges effectively to meet project needs and company objectives.
• Oversee and direct the development of priorities, timelines, receipt of technical information from appropriate sources, and the preparation of regulatory documentation for new products, amendments of approved products, and submissions that support the maintenance of existing licenses.
• Support the implementation of policies, procedures, practices, and strategies to facilitate support of in-country product registrations in APAC.
• Work closely with the regional APAC regulatory team to develop and drive process efficiencies for APAC regulatory submissions.
• Review and evaluate issues that may create regulatory or business obstacles and propose solutions.
• Monitor APAC regulations/guidelines and the impact of changing/evolving regulations on submissions, practices, and procedures, and communicate to appropriate stakeholders.
• Manage the performance and career development of direct reports.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor's degree required, 5 years direct experience in Regulatory Affairs in a Medical Device Company required.
• Knowledge and Skill Requirements/Specialized Courses and/or Training.
• Strong interpersonal and communication skills.
• Proficient in Microsoft Office.
• Advanced written communication skills.

The listing includes standard statements about reasonable accommodations for applicants with disabilities and general workplace expectations.

Responsibilities

• The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory department.
• Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams.
• Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations, coordinating regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
• Document regulatory strategies for product submissions.
• Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays.
• Prepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assays.
• Facilitate FDA pre-submission meetings.
• Support EU representatives in their creation of CE/IVD Technical Files.
• Support global regulatory registration representatives for product registration activities.
• Perform regulatory assessment of new and changed products.
• Stay on top of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
• Conduct training and/or communicate appropriate materials, as needed, to improve the team's knowledge of working in a regulated environment.
• Participate in business meetings with potential new external partners.
• Assist the Regulatory department in updating, improving, and crafting internal policies and procedures.

• B.Sc. or equivalent experience in Biology, Chemistry, bioengineering, or related science at least 5 years of IVD Regulatory Affairs experience.
• Hands-on experience with 510(k), PMA, and PMA supplement submissions.
• Knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
• Ability to lead multiple projects and meet deadlines.
• Strong communication and teamwork skills.
• Capacity to communicate regulations to technical functions within the company.
• Experience as the RA representative on project core teams.

Overview

In this critical role, you will lead regulatory strategies, product submissions, and a team of regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more.

• You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
• Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management.
• Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies.
• Oversee and coach a team of regulatory professionals to support both strategic and operational objectives.
• Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.).
• Define and execute submission strategies to meet timelines and business goals.
• Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review.
• Monitor changes in international regulatory environments and communicate impacts to internal teams.
• Represent the company in industry groups or regulatory associations, where appropriate.
• Support training and knowledge-sharing on country-specific regulatory requirements within the organization.

• BS/MS degree or equivalent experience required.
• Expertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDR.
• Superior presentation skills when communicating with all levels of the organization, business partners, and external sources.
• Ability to work with evolving technologies, systems, and global teams in a fast-paced, matrixed environment.
• Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.

Join to apply for the Regulatory Affairs Associate role at Katalyst CRO

• Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).
• Provides regulatory support for diagnostic product development and commercial diagnostic products.
• Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally.
• Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
• Researches and communicates scientific and regulatory information to write submission documents.
• Compiles and publishes all material required for submissions, license renewals, and annual registrations.
• Maintains approvals/licenses/authorizations for existing marketing authorizations.
• Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
• Develops internal procedures and tools.
• Conducts informational or training sessions for stakeholders.
• Organizes and maintains hard copy and electronic department files.
• Demonstrates commitment to the development, implementation, and effectiveness of Client Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.

• Bachelor's degree in biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.
• 4+ years' experience in Regulatory Affairs role.
• Strong knowledge of IVDR and EU regulatory requirements is required.
• Good knowledge of EU and international regulations.
• Demonstrated written and verbal communication skills.
• Strong time management skills, with the ability to work on multiple projects simultaneously.
• Ability to work independently as well as within a team.
• Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Visio.

Overview

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.

Specific Education & Experience Requirements:

• 5+ years of experience in Regulatory Affairs or other relevant industry experience.
• Degree in a scientific field is preferred.

• Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• Responsible for submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications (e.g. IND, CTAs), and marketing authorizations, original, marketing authorization applications for territories other than the US and EU and for contributing to preparation of US and EU marketing authorizations.
• Provides regulatory expertise to labeling changes and to submission teams on specified projects and topics.
• Provides input to senior Regulatory Affairs professionals in the preparation of country specific labeling.
• May be responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licenses.
• Participate in group meetings and local and global product submission team meetings and present project status updates and strategy approaches to moderately complex programs/projects.
• Responsible under guidance of immediate manager for own self-development and acquisition of required regulatory skills and knowledge.
• Initiates or contribute to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments.
• Excellent organization skills and ability to work on a number of projects with tight timelines is required.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories. Is recognized as a knowledgeable resource within the department on a range of topics.
• Work is performed under minimal direction of a senior Regulatory Affairs professional.

The salary range for this position is:

• Bay Area: $146,540.00 - $89,640.00
• Other US Locations: 133,195.00 - 172,370.00

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 the URL below.

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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. For jobs in the United States, Gilead also provides information about other policies and notices.

Our 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.

Please apply via the Internal Career Opportunities portal in Workday for current Gilead employees and contractors.