3,597 Head Of Regulatory jobs in the United States
VP / Head of Regulatory Affairs
Posted today
Job Viewed
Job Description
A privately held, clinical-stage biotechnology company is seeking a Vice President / Head of Regulatory Affairs to join its leadership team. This role will be pivotal in shaping and executing global regulatory strategies to support the development of novel therapies targeting neurological and neuroinflammatory conditions.
The company is advancing a pipeline of small molecule candidates aimed at addressing unmet needs in complex diseases of the nervous system. The environment is fast-paced, mission-driven, and highly collaborative.
Key Responsibilities
- Lead the development and execution of global regulatory strategies across early and mid-stage clinical programs
- Oversee regulatory submissions including INDs, CTAs, briefing packages, and designation requests
- Serve as the primary liaison with global health authorities (FDA, EMA, etc.)
- Provide strategic regulatory guidance to cross-functional teams including clinical, R&D, manufacturing, and quality
- Monitor regulatory trends and ensure compliance across programs
- Manage external regulatory consultants and vendors
- Build and mentor a high-performing regulatory team
Qualifications
- Advanced degree in a scientific discipline (PharmD, PhD, MD preferred)
- 12+ years of regulatory affairs experience in biotech/pharma, including leadership roles
- Experience with CNS or neuro-related programs is a plus
- Proven success in both large and small company environments
- Strong knowledge of global regulatory requirements and pathways
- Demonstrated success in regulatory submissions and approvals
- Excellent leadership, communication, and cross-functional collaboration skills
Additional Information
- Location: Bay Area preferred
- Competitive compensation package including equity, comprehensive health benefits, and retirement plan
If you are passionate about advancing science in a dynamic, entrepreneurial setting, we encourage you to apply.
Senior Director, Regulatory Affairs, Head of Regulatory Advertising and Promotion
Posted 1 day ago
Job Viewed
Job Description
This role is the head of Promotional Regulatory, and provides regulatory leadership, support, oversight, and strategic guidance on promotional and non-promotional communications or activities for BeOne Medicines marketed products in North America with some activity globally. This role supports our commercial, medical affairs, legal, healthcare compliance and other business functions primarily in the United States with some activities globally to ensure compliance with applicable regulatory requirements and guidelines, and consistency with approved labeling. The role also is expected to work closely with our in-house commercial, legal and regulatory colleagues in Europe, China and other regions to ensure global coordination of promotional and non-promotional product communications/activities and ensure compliance with company policies and international guidelines.
**Essential Functions of the job:**
+ Oversees the regulatory review process for promotional materials in conformance with local regulatory requirements and company policy, and to ensure consistency with approved labeling.
+ Provide advice and guidance on healthcare regulations applicable to the development and commercialization of BeOne's medicines and product candidates in North America.
+ Provide strategic guidance on commercial product labeling as part of the Labeling Working Group.
+ Serve as the lead regulatory representative on various cross-functional teams, including promotional and medical review committees. Supports direct reports who may attend cross-functional team meetings.
+ Collaborate and participate on cross-functional teams for product labeling, product development teams, medical affairs, and marketing.
+ Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, medical affairs, patient safety, legal, and healthcare compliance.
+ Review and provide guidance on a wide range of promotional and nonpromotional materials, including branded promotional materials, disease education/disease awareness campaigns, scientific communications, speaker programs, patient education materials, grants and sponsorships, training materials, and reprint and publications plans.
+ Provide regulatory advice on appropriate relationships with healthcare professionals, patients, managed care entities, advocacy organizations, and government entities, consistent with relevant regulations, guidance documents, and current enforcementtrends.
+ Review and advise on healthcare regulatory matters in BeOne's external communications, such as scientific journal articles, abstracts, presentations at medical conferences, press releases, and investor presentations.
+ Advise and train on the Food, Drug and Cosmetic Act, FDA guidance documents, industry codes and standards (e.g., PhRMA, ICMJE, ACCME), and other laws and regulations applicable to the development and commercialization of pharmaceutical products.
+ Assist with the development and implementation of policies and procedures related to healthcare compliance in the area of promotional and non-promotional communications and activities.
+ Liaises and negotiates with regulatory authorities as needed for all aspects pertaining to promotional activities including resolution of key regulatory issues.
+ Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business.
+ Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
+ Recruits, develops, manages and mentors regulatory professionals and helps create a goal- oriented culture.
**Supervisory Responsibilities:**
+ Will manage direct reports involved in both promotional/ publication strategies and operational activities for the various approved assets and those in development.
**Education/Experience Required:**
+ Bachelor's degree (BS/BSc or BA), preferably in a scientific or health-related discipline, with at least 12+ years of experience in regulatory affairs, in advertising/promotion, labeling or related discipline
+ and 5 years of supervisory/management experience, or the equivalent combination of education and relevant experience.
+ Broad and comprehensive knowledge commercial compliance requirements, including regulations and guidelines for promotional and non-promotional product communications.
+ Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.
+ Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.
+ Proficient ability in managing the financial and operating performance for a team.
+ Track record of building and leading high-performance teams.
+ Excellent oral and written communication skills are a must, as are superior planning skills.
+ The candidate should be detailed-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.
+ Ability to work in a team environment with all levels of cross functional partners
**Computer Skills:** Proficiency in MS Office Suite applications and document management systems.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Senior Director, Regulatory Affairs, Head of Regulatory Advertising and Promotion
Posted 1 day ago
Job Viewed
Job Description
This role is the head of Promotional Regulatory, and provides regulatory leadership, support, oversight, and strategic guidance on promotional and non-promotional communications or activities for BeOne Medicines marketed products in North America with some activity globally. This role supports our commercial, medical affairs, legal, healthcare compliance and other business functions primarily in the United States with some activities globally to ensure compliance with applicable regulatory requirements and guidelines, and consistency with approved labeling. The role also is expected to work closely with our in-house commercial, legal and regulatory colleagues in Europe, China and other regions to ensure global coordination of promotional and non-promotional product communications/activities and ensure compliance with company policies and international guidelines.
**Essential Functions of the job:**
+ Oversees the regulatory review process for promotional materials in conformance with local regulatory requirements and company policy, and to ensure consistency with approved labeling.
+ Provide advice and guidance on healthcare regulations applicable to the development and commercialization of BeOne's medicines and product candidates in North America.
+ Provide strategic guidance on commercial product labeling as part of the Labeling Working Group.
+ Serve as the lead regulatory representative on various cross-functional teams, including promotional and medical review committees. Supports direct reports who may attend cross-functional team meetings.
+ Collaborate and participate on cross-functional teams for product labeling, product development teams, medical affairs, and marketing.
+ Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, medical affairs, patient safety, legal, and healthcare compliance.
+ Review and provide guidance on a wide range of promotional and nonpromotional materials, including branded promotional materials, disease education/disease awareness campaigns, scientific communications, speaker programs, patient education materials, grants and sponsorships, training materials, and reprint and publications plans.
+ Provide regulatory advice on appropriate relationships with healthcare professionals, patients, managed care entities, advocacy organizations, and government entities, consistent with relevant regulations, guidance documents, and current enforcementtrends.
+ Review and advise on healthcare regulatory matters in BeOne's external communications, such as scientific journal articles, abstracts, presentations at medical conferences, press releases, and investor presentations.
+ Advise and train on the Food, Drug and Cosmetic Act, FDA guidance documents, industry codes and standards (e.g., PhRMA, ICMJE, ACCME), and other laws and regulations applicable to the development and commercialization of pharmaceutical products.
+ Assist with the development and implementation of policies and procedures related to healthcare compliance in the area of promotional and non-promotional communications and activities.
+ Liaises and negotiates with regulatory authorities as needed for all aspects pertaining to promotional activities including resolution of key regulatory issues.
+ Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business.
+ Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
+ Recruits, develops, manages and mentors regulatory professionals and helps create a goal- oriented culture.
**Supervisory Responsibilities:**
+ Will manage direct reports involved in both promotional/ publication strategies and operational activities for the various approved assets and those in development.
**Education/Experience Required:**
+ Bachelor's degree (BS/BSc or BA), preferably in a scientific or health-related discipline, with at least 12+ years of experience in regulatory affairs, in advertising/promotion, labeling or related discipline
+ and 5 years of supervisory/management experience, or the equivalent combination of education and relevant experience.
+ Broad and comprehensive knowledge commercial compliance requirements, including regulations and guidelines for promotional and non-promotional product communications.
+ Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.
+ Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.
+ Proficient ability in managing the financial and operating performance for a team.
+ Track record of building and leading high-performance teams.
+ Excellent oral and written communication skills are a must, as are superior planning skills.
+ The candidate should be detailed-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.
+ Ability to work in a team environment with all levels of cross functional partners
**Computer Skills:** Proficiency in MS Office Suite applications and document management systems.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Project Manager, Legal/Compliance
Posted 3 days ago
Job Viewed
Job Description
Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889.
Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring principles of service, expertise, and integrity. With more than 130 years of financial experience and over 22,000 partners, we serve the world's most sophisticated clients using leading technology and exceptional service.
Role: Project Manager, Legal/Compliance
This position reports to the ERISA Attorney within our Legal Department. This role will focus supporting ERISA Attorney and ERISA Compliance with respect to Northern Trust's compliance with the Employee Retirement Income Security Act of 1974, as amended ("ERISA") and the parallel provisions under the Internal Revenue Code of 1986, as amended (the "Code").
The key responsibilities of the role include:
• Oversees projects related to Northern's ongoing compliance with ERISA and the Code, as applicable.
• Collaborates with key stakeholders to define a project's scope and objectives to align with Northern's ERISA compliance-related goals.
• Develops and maintains appropriate project timelines and attends to allocating resources.
• Develops and oversees timely internal reporting regarding projects.
• Provides support, as necessary, in responding to regulatory inquiries, examinations, and subpoenas from the Department of Labor, Internal Revenue Service, and Pension Benefit Guaranty Corporation.
• Effectively and respectfully interacts with partners (e.g., relationship managers, Risk/Compliance, Tax, Legal Department, Human Resources) or external parties (e.g., regulators, other financial institutions, investigations staff), as appropriate.
Skills/Qualifications:
• Bachelor's degree in Finance, Business, Law, or a related field; PMP certification preferred.
• Minimum 5+ years of experience in project support for regulatory compliance, change management, or related fields
• In-depth Functional / Industry Knowledge is required
• Proven track record of driving strategic transformation at the enterprise level
• Prior experience with financial institutions.
• Experience working on regulatory projects and/or internal audit & remediation projects.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently and collaboratively in a team environment.
• Excellent oral and written communication skills are required
• Highly flexible and adaptable to change
Working Model: Hybrid (#LI-Hybrid)
We have a balanced hybrid working model to ensure you get the flexibility you need, and the successful candidate will spend their time between working in the office and working from home.
Salary Range:
$83,100 - 141,300 USD
Salary range is a good faith estimate of base pay. Northern Trust provides a comprehensive benefits package including retirement benefits (401k and pension), health and welfare benefits (medical, dental, vision, spending accounts and disability), paid time off, parental and caregiver leave, life & accident insurance, and other voluntary and well-being benefits. Northern Trust also provides a discretionary bonus program that may include an equity component.
Working with Us:
As a Northern Trust partner, greater achievements await. You will be part of a flexible and collaborative work culture in an organization where financial strength and stability is an asset that emboldens us to explore new ideas.
Movement within the organization is encouraged, senior leaders are accessible, and you can take pride in working for a company committed to assisting the communities we serve! Join a workplace with a greater purpose.
We'd love to learn more about how your interests and experience could be a fit with one of the world's most admired and sustainable companies! Build your career with us and apply today. #MadeForGreater
Reasonable accommodation
Northern Trust is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please email our HR Service Center at
We hope you're excited about the role and the opportunity to work with us. We value an inclusive workplace and understand flexibility means different things to different people.
Apply today and talk to us about your flexible working requirements and together we can achieve greater.
VP / Head of Regulatory Affairs (San Mateo County)
Posted today
Job Viewed
Job Description
A privately held, clinical-stage biotechnology company is seeking a Vice President / Head of Regulatory Affairs to join its leadership team. This role will be pivotal in shaping and executing global regulatory strategies to support the development of novel therapies targeting neurological and neuroinflammatory conditions.
The company is advancing a pipeline of small molecule candidates aimed at addressing unmet needs in complex diseases of the nervous system. The environment is fast-paced, mission-driven, and highly collaborative.
Key Responsibilities
- Lead the development and execution of global regulatory strategies across early and mid-stage clinical programs
- Oversee regulatory submissions including INDs, CTAs, briefing packages, and designation requests
- Serve as the primary liaison with global health authorities (FDA, EMA, etc.)
- Provide strategic regulatory guidance to cross-functional teams including clinical, R&D, manufacturing, and quality
- Monitor regulatory trends and ensure compliance across programs
- Manage external regulatory consultants and vendors
- Build and mentor a high-performing regulatory team
Qualifications
- Advanced degree in a scientific discipline (PharmD, PhD, MD preferred)
- 12+ years of regulatory affairs experience in biotech/pharma, including leadership roles
- Experience with CNS or neuro-related programs is a plus
- Proven success in both large and small company environments
- Strong knowledge of global regulatory requirements and pathways
- Demonstrated success in regulatory submissions and approvals
- Excellent leadership, communication, and cross-functional collaboration skills
Additional Information
- Location: Bay Area preferred
- Competitive compensation package including equity, comprehensive health benefits, and retirement plan
If you are passionate about advancing science in a dynamic, entrepreneurial setting, we encourage you to apply.
Legal & Compliance Coordinator
Posted 1 day ago
Job Viewed
Job Description
Job DescriptionJob Description
We are seeking a Legal & Compliance Coordinator with a proven background in RegTech and IDV to join our growing team at Programmers Force. In this role, you will support compliance and legal teams in managing documentation, contracts, and regulatory requirements.
Key Responsibilities:
- Assist with contract management and legal documentation.
- Support compliance audits and reporting.
- Track regulatory updates and ensure documentation accuracy.
- Coordinate with internal teams on legal and compliance requirements.
Requirements
- 2–4 years of experience in legal, compliance, or administrative roles.
- Knowledge of AML/KYC/IDV regulations is a plus.
- Strong organizational and detail- skills.
- Excellent communication and coordination abilities.
Legal & Compliance Coordinator
Posted 1 day ago
Job Viewed
Job Description
Job DescriptionJob Description
We are seeking a Legal & Compliance Coordinator with a proven background in RegTech and IDV to join our growing team at Programmers Force. In this role, you will support compliance and legal teams in managing documentation, contracts, and regulatory requirements.
Key Responsibilities:
- Assist with contract management and legal documentation.
- Support compliance audits and reporting.
- Track regulatory updates and ensure documentation accuracy.
- Coordinate with internal teams on legal and compliance requirements.
Requirements
- 2–4 years of experience in legal, compliance, or administrative roles.
- Knowledge of AML/KYC/IDV regulations is a plus.
- Strong organizational and detail- skills.
- Excellent communication and coordination abilities.
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Lead, Legal Compliance
Posted 2 days ago
Job Viewed
Job Description
L3Harris is dedicated to recruiting and developing high-performing talent who are passionate about what they do. Our employees are unified in a shared dedication to our customers' mission and quest for professional growth. L3Harris provides an inclusive, engaging environment designed to empower employees and promote work-life success. Fundamental to our culture is an unwavering focus on values, dedication to our communities, and commitment to excellence in everything we do.
L3Harris Technologies is the Trusted Disruptor in the defense industry. With customers' mission-critical needs always in mind, our employees deliver end-to-end technology solutions connecting the space, air, land, sea and cyber domains in the interest of national security.
Job Title: Lead, Legal Compliance
Job Code: 28919
Job Location: Camden NJ, Herndon VA, Northampton MA or Anaheim CA.
Schedule: 9/80 Every other Friday off
Job Description:
At L3Harris, integrity and ethical business practices are fundamental to our success. Our Anti-Corruption (AC) Program ensures that L3Harris, its employees, and third parties operate with transparency and in strict compliance with Anti-Corruption laws in every country where we do business. The AC Program promotes adherence to our zero-tolerance policy on bribery, kickbacks, and improper influence, setting a high bar for ethical responsibility in the global aerospace and defense industry.
Reporting to the Segment Anti-Corruption Officer (SACO) for the Integrated Mission Systems (IMS) Segment, the Lead, Legal Compliance will play a strategic role in ensuring AC compliance within the Maritime sector. As the sector's primary Anti-Corruption Advisor (ACA) and Due Diligence Professional (DDP), you will be responsible for deploying, executing, and monitoring the AC Program, including due diligence on third-party representatives, risk mitigation plans, audits, and controls. This critical role will have strong visibility with internal and external stakeholders and will directly contribute to aligning corporate compliance practices with business priorities.
The Lead, Legal Compliance:
- Actively participates in discussions with business development and other sector stakeholders as needed to advise on compliance policy, procedures and risks identified in the involvement of third parties to enable business strategies and market priorities.
- Engages with sales Consultants, Distributors and Representatives (CDRs) and other third parties for performance of due diligence as required by L3Harris policy, while prioritizing files in accordance with business strategies.
- Supports investigation, assessment and risk mitigation of red flags identified during due diligence or as may arise during the relationship with the third parties.
- Drafts complex agreements for the engagement of CDRs, while working along with SACO, Legal Counsel and/or Contracts as needed to ensure strong risk mitigating provisions while addressing business requirements.
- Develops and deploys specialized Anti-Corruption training for sector stakeholders aiming at enhancing program awareness and compliance.
- Reviews high risk payments prior to issuance, including review of eligible commission, to ensure payments are made in accordance with the agreements and that proper due diligence has been conducted on the proposed recipient.
- Reviews requests to provide business courtesies to third parties or request to accept business courtesies offered to L3Harris employees, which includes assessment of applicable laws and policies, review of business rationale, identify red flags and coordinate as needed with SACO and CHQ Anti-Corruption.
- Support internal and external audits as it relates to the AC program, CDRs and/or business courtesies.
- In collaboration with functional leaders within sector and divisions, lead the implementation of local AC processes and AC controls listed in L3Harris' Internal Control over Financial Reporting (ICFR) framework; as well as the remediation plans when control failures are identified through Internal Audit or compliance testing.
- Provides quarterly certification of AC compliance in the Management Representation Letter for designated divisions and oversees the preparation of quarterly Anti-Corruption Data Reports, as applicable under AC ICFR framework.
- Bachelor's Degree and minimum 6 years of prior relevant experience in legal compliance including performance of third-party due diligence.
- Graduate Degree and a minimum of 4 years of prior related experience. In lieu of a degree, minimum of 13 years of prior related experience.
- Strong business acumen with a well-developed compliance mindset
- Experience in agreement drafting, including the ability to translate business needs and risk mitigation plans into contractual provisions
- Excellent verbal and written communication in English
- Excellent attention to detail, high level of accuracy, and willingness to take initiative; self-starter who is organized and able to work without close supervision; proven agility in a fast-paced environment
- Ability to handle multiple tasks and effectively balance priorities to meet deadlines
- Good organizational, project management, analytical and problem-solving skills
- Articulate, able to liaise with internal and external stakeholders, including company leadership
- Ability to analyze large quantities of information to prepare reports
- Strong sense of accountability, ownership, and responsibility
- Demonstrated experience understanding complex policy and procedural requirements; ability to identify, evaluate and propose solutions where necessary
- May have broad knowledge of project management.
- Foreign language would be an asset
- Prior exposure to financial controls, and auditing would be an asset
In compliance with pay transparency requirements, the salary range for this role in Colorado State, Hawaii, Illinois, Maryland, Minnesota, Vermont and New York State is $94K-$74K. For California, New Jersey, Seattle, Washington D.C., Maryland Greater Washington D.C. area, the city of Denver, Washington State and New York City, the salary range for this role is 108- 201K. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. L3Harris also offers a variety of benefits, including health and disability insurance, 401(k) match, flexible spending accounts, EAP, education assistance, parental leave, paid time off, and company-paid holidays. The specific programs and options available to an employee may vary depending on date of hire, schedule type, and the applicability of collective bargaining agreements.
#LI-LT1
L3Harris Technologies is proud to be an Equal Opportunity Employer. L3Harris is committed to treating all employees and applicants for employment with respect and dignity and maintaining a workplace that is free from unlawful discrimination. All applicants will be considered for employment without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender (including pregnancy, childbirth, breastfeeding or other related medical conditions), gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, characteristic or membership in any other group protected by federal, state or local laws. L3Harris maintains a drug-free workplace and performs pre-employment substance abuse testing and background checks, where permitted by law.
Please be aware many of our positions require the ability to obtain a security clearance. Security clearances may only be granted to U.S. citizens. In addition, applicants who accept a conditional offer of employment may be subject to government security investigation(s) and must meet eligibility requirements for access to classified information.
By submitting your resume for this position, you understand and agree that L3Harris Technologies may share your resume, as well as any other related personal information or documentation you provide, with its subsidiaries and affiliated companies for the purpose of considering you for other available positions.
L3Harris Technologies is an E-Verify Employer. Please click here for the E-Verify Poster in English or Spanish . For information regarding your Right To Work, please click here for English or Spanish .
Legal & Compliance Coordinator
Posted 2 days ago
Job Viewed
Job Description
We are seeking a Legal & Compliance Coordinator with a proven background in RegTech and IDV to join our growing team at Programmers Force. In this role, you will support compliance and legal teams in managing documentation, contracts, and regulatory requirements.
Responsibilities- Assist with contract management and legal documentation.
- Support compliance audits and reporting.
- Track regulatory updates and ensure documentation accuracy.
- Coordinate with internal teams on legal and compliance requirements.
- 24 years of experience in legal, compliance, or administrative roles.
- Knowledge of AML/KYC/IDV regulations is a plus.
- Strong organizational and detail-oriented skills.
- Excellent communication and coordination abilities.
#J-18808-Ljbffr
Legal & Compliance Coordinator
Posted 2 days ago
Job Viewed
Job Description
Job DescriptionJob Description
We are seeking a Legal & Compliance Coordinator with a proven background in RegTech and IDV to join our growing team at Programmers Force. In this role, you will support compliance and legal teams in managing documentation, contracts, and regulatory requirements.
Key Responsibilities:
- Assist with contract management and legal documentation.
- Support compliance audits and reporting.
- Track regulatory updates and ensure documentation accuracy.
- Coordinate with internal teams on legal and compliance requirements.
Requirements
- 2–4 years of experience in legal, compliance, or administrative roles.
- Knowledge of AML/KYC/IDV regulations is a plus.
- Strong organizational and detail- skills.
- Excellent communication and coordination abilities.