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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in FDA Advertising & Promotion regulations, providing strategic regulatory guidance and ensuring compliance in promotional materials. Proven ability to collaborate with cross-functional teams and mentor junior members while adapting regulatory strategies to evolving industry trends.
Highest-signal resume keywords
Regulatory Affairs ExperienceFDA Advertising & Promotion ExpertiseStrategic Advisory SkillsStakeholder ManagementCritical Thinking
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Compliance ReviewFDA Guidance InterpretationRisk AssessmentPromotional Material ApprovalRegulatory Strategy Adaptation
Soft Skills
Excellent CommunicationInfluence SkillsProblem-Solving AbilitiesProactive Mindset
Industry Keywords
Pharmaceutical IndustryBiotech IndustryMedical Device IndustryRegulatory Review CommitteesGlobal Regulatory Considerations
About the role
Key responsibilities & impact- Serve as a strategic regulatory partner to Medical Affairs, Legal, Commercial, Marketing, and Clinical teams
- Act as a subject matter expert in FDA Advertising & Promotion regulations
- Provide high-level guidance on complex regulatory scenarios
- Independently review and approve promotional and non-promotional materials for regulatory compliance
- Interpret and apply FDA guidance to identify risks and opportunities
- Adapt regulatory strategy based on evolving FDA expectations, enforcement trends, and business needs
- Provide strategic input on messaging, claims, and communication strategy during development
- Partner with Legal and Medical Affairs on balanced, compliant, and scientifically accurate communications
- Lead risk assessment and mitigation discussions
- Support or lead regulatory review committees
- Monitor regulatory trends, FDA enforcement actions, and industry best practices
- Mentor junior team members and build organizational regulatory capability
Requirements
What you’ll need- 7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & Promotion
- Deep and demonstrated knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities
- Proven ability to act as a strategic advisor and trusted partner to senior stakeholders
- Extensive experience collaborating with Medical Affairs, Legal, and Commercial teams
- Demonstrated ability to independently review promotional materials and make sound regulatory decisions
- Strong experience in interpreting and applying FDA guidance to real-world scenarios, including the ability to adapt strategies accordingly
- Excellent communication, influence, and stakeholder management skills
- Strong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindset
- Experience supporting product launches or high-visibility brands preferred
- Familiarity with global regulatory considerations preferred
- Prior experience leading or facilitating regulatory review committees preferred
Benefits
Comp & perks- Health, Vision & Dental Insurance
- Tuition Reimbursement
- Vacation/Holiday/Sick Time
- Flexible Spending & Health Savings Accounts
- Work/Life Balance
- 401(k) with Company match
- Pet Insurance
- Paid time off
- Life insurance
- Additional benefit offerings in accordance with applicable plans
- Potential eligibility for additional incentives, bonuses, or other compensation programs