Regulatory Affairs Senior Manager, Regulatory Promotion & Material Compliance
New
Based in the United StatesFull-TimeManager
Salary$142,579 – $192,901 USD
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Job Details
- Experience
- Bachelor’s + 6 years, Master’s + 4 years, or equivalent experience
- Required Skills
- Project ManagementMentoringStakeholder management
Requirements
- Advanced degree in life sciences, pharmacy, medicine, or related field.
- Significant regulatory experience (Bachelor’s + 6 years, Master’s + 4 years, or equivalent).
- Strong expertise in FDA promotional regulations within a 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.
- 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.
Responsibilities
- 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.
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