Assoc Director, Regulatory Affairs – Advertising and Promotion

MSD

Associate Director managing US promotional materials and serving as regulatory expert. Collaborating with legal and commercial teams to ensure compliance with FDA regulations.

Posted 6/9/2026full-timeNorth Wales • New Jersey, Pennsylvania • 🇺🇸 United StatesLead💰 $129,000 - $203,100 per yearWebsite

About the role

Key responsibilities & impact

responsible for the review and approval of all US promotional materials
serving as the promotional regulatory expert with legal, medical and commercial colleagues
serve as the liaison and manage correspondence with FDA’s promotional review divisions OPDP/APLB
propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts
provide regulatory consultation in the development and implementation of US marketing strategy and promotional programs
support the US commercial teams by participating in strategy discussions and providing regulatory guidance
provide promotional regulatory input on concepts and draft materials
actively participate in labeling and global regulatory team meetings
maintain current awareness and understanding of FDA advisory correspondence and regulations
ability to take on more complex projects and provide promotional regulatory training and coaching to team members

Requirements

What you’ll need

B.A. or B.S. degree with an emphasis in science, health care or related fields
Minimum of five years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines
Minimum of two years of direct experience as the primary regulatory reviewer of advertising and promotional materials
Demonstrated knowledge of FDA regulations relating to advertising and promotion for prescription products
Proactive with strong cross-functional collaboration skills
Demonstrated history of successful interactions with the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch
Understanding of the product development and labeling process
Excellent verbal and written communication skills
Attention to detail and ability to manage multiple priorities simultaneously
Strong interpersonal skills with ability to demonstrate strategic and analytical thinking
Demonstrated ability to negotiate and influence others effectively

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory reviewpromotional materialsFDA regulationsadvertising compliancepromotional strategieslabeling processregulatory consultationmarketing strategypromotional programsregulatory training

Soft Skills

cross-functional collaborationcommunication skillsattention to detailstrategic thinkinganalytical thinkingnegotiation skillsinfluence skillsproject managementcoachingproblem-solving

Certifications

B.A. or B.S. degree