Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance
Job Description
Team: Legal
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs Senior Manager, Regulatory Promotion & Material Compliance based in the United States.
This role is a strategic regulatory leadership position focused on ensuring that promotional and scientific communications for pharmaceutical products meet strict FDA requirements and remain accurate, balanced, and compliant. You will serve as a key authority in interpreting evolving regulatory guidance and translating it into clear, actionable standards for promotional review activities across products and disease areas. Acting as a trusted advisor within a highly collaborative environment, you will help shape compliant communication strategies that support both marketed and pipeline therapies. The role involves reviewing promotional materials, guiding cross-functional stakeholders, and ensuring alignment with regulatory expectations in a fast-paced biotech setting. You will also mentor junior reviewers and contribute to strengthening internal regulatory capabilities. This is a high-impact role suited for a detail-oriented regulatory expert who thrives at the intersection of science, compliance, and strategic communication.
Accountabilities:
- Provide strategic regulatory guidance for promotional and disease-related communications, ensuring compliance with FDA requirements and internal standards.
- Review and evaluate promotional materials through promotional review committees, assessing scientific accuracy, supporting evidence, and compliance alignment.
- Interpret evolving regulatory guidance and enforcement trends to assess business and product impact.
- Define and communicate regulatory promotional positions for approved and pipeline products.
- Identify required changes to promotional content to ensure adherence to regulatory standards.
- Monitor external regulatory developments, congress insights, and industry trends and share key learnings with internal teams.
- Mentor and support development of associate and manager-level regulatory reviewers.
- Collaborate cross-functionally with clinical, commercial, and legal teams to ensure compliant messaging across all materials.
- Provide expert judgment on data interpretation and its appropriate application in promotional contexts.
- Advanced degree in life sciences, pharmacy, medicine, or related field with significant regulatory experience (Bachelor’s + 6 years, Master’s + 4 years, or equivalent experience).
- Strong expertise in FDA promotional regulations and experience applying them in a dynamic pharmaceutical or biotech environment.
- Proven experience in promotional review committees and regulatory review of commercial or scientific materials.
- Strong analytical and critical thinking skills with the ability to interpret complex scientific and regulatory information.
- Excellent communication, negotiation, and stakeholder management skills across cross-functional teams.
- Demonstrated ability to influence decisions and provide regulatory leadership in a matrix environment.
- Experience mentoring or coaching junior regulatory professionals.
- Strong organizational, project management, and time management skills.
- Ability to work independently while exercising sound judgment in high-stakes compliance decisions.
- Competitive annual salary range: $142,579 – $192,901 USD.
- Comprehensive healthcare coverage including medical, dental, and vision insurance.
- Retirement and savings plan with employer contributions.
- Annual bonus eligibility and long-term stock-based incentives.
- Flexible work arrangements where applicable.
- Generous paid time off and flexible time-off programs.
- Life, disability, and supplemental insurance coverage.
- Health savings and flexible spending account options.
- Strong focus on career development, mentorship, and internal growth opportunities.
- Inclusive, science-driven culture focused on innovation and patient impact.
Requirements:
Benefits:
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Date Posted
06/25/2026
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