The Associate Director RA serves as the regulatory lead on relative Review Committees (RCs), working with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies for the advertising and promotion of prescription drugs and biologics
Job Summary
The Associate Director RA serves as the regulatory lead on relative Review Committees (RCs), working with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies for the advertising and promotion of prescription drugs and biologics.
Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials.
Bring the miracles of science to life alongside a supportive, future-focused team.
Matching Summary
The Associate Director RA serves as the regulatory lead on relative Review Committees (RCs), working with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies for the advertising and promotion of prescription drugs and biologics.
Salary
Base: $148,500.00 - $214,500.00; Bonus/Equity: Not specified; Benefits: Employees may be eligible to participate in Company employee benefit programs.
Skills & Requirements
Must-have
Regulatory leadership for advertising materials
FDA regulations for prescription drugs
Review Committee leadership
Compliance with federal regulations
Advertising and promotion liaison with FDA
Nice-to-have
AI-powered research
Deep immunoscience understanding
Cross-functional team facilitation
Innovative solution generation
Customer focus and negotiation skills
Key Requirements
5+ years pharmaceutical Regulatory Affairs experience
3+ years advertising & promotion experience
Bachelor's degree in Life Sciences
Leadership, mentoring, or training experience preferred