Associate Director, Regulatory Affairs - Advertising and Promotion

MSD•Rahway, PA

2d•Hybrid

About The Position

The Associate Director, Regulatory Affairs is responsible for reviewing and approving U.S. promotional materials and serving as the promotional regulatory expert for legal, medical, and commercial colleagues. The role ensures promotional practices align with regulatory guidelines, company policies, and business objectives. It serves as liaison with FDA promotional review divisions OPDP/APLB, managing correspondence, complex regulatory questions, and submissions for advisory comment. The position develops creative, effective, and compliant regulatory strategies for challenging promotional concepts, provides regulatory consultation on U.S. marketing strategy and promotional programs, and supports commercial teams through strategy discussions and extended team meetings. It gives regulatory input on concepts and draft materials, and participates in labeling and global regulatory team meetings to support anticipated promotional messages and claims in clinical trial design and product labeling. The Associate Director maintains current knowledge of FDA advisory correspondence, regulations, guidance, enforcement letters, and policy issues affecting the pharmaceutical and biologics industries. The role also takes on complex projects, provides promotional regulatory training and coaching, and contributes to departmental strategic initiatives that improve effective, compliant promotional regulatory review. This is a hybrid position requiring onsite work three days per week in Upper Gwynedd, PA, or Rahway, NJ.

Requirements

Bachelor of Arts or Bachelor of Science degree with an emphasis in science, health care, or related fields.
At least five years of pharmaceutical/biologics industry or related experience, with an emphasis in regulatory or scientific disciplines.
At least 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 approach and strong cross-functional collaboration skills.
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 and ability to demonstrate strategic and analytical thinking.
Demonstrated ability to negotiate and influence others effectively.
Ability to work onsite three days per week in Upper Gwynedd, PA, or Rahway, NJ.

Nice To Haves

Master’s, PhD, or PharmD degree with an emphasis in science, health care, or related fields.
History of successful interactions with FDA promotional review divisions OPDP/APLB, or experience developing or leading regulatory strategy for a product filing or launch.

Responsibilities

Review and approve U.S. promotional materials.
Serve as the promotional regulatory expert to legal, medical, and commercial colleagues, ensuring promotional practices comply with regulatory guidelines and company policies while supporting business objectives.
Liaise with FDA promotional review divisions OPDP/APLB and manage correspondence, complex regulatory questions, and submissions for advisory comment.
Propose compliant regulatory strategies and solutions for challenging promotional concepts while meeting business objectives and minimizing regulatory risk.
Provide regulatory consultation during the development and implementation of U.S. marketing strategies and promotional programs.
Support U.S. commercial teams by participating in strategy discussions and extended team meetings and providing regulatory guidance on marketing strategies, promotional objectives, and tactics.
Provide promotional regulatory input on concepts and draft materials to support alignment with U.S. promotional regulations, corporate standards and policies, and business objectives.
Participate in labeling and global regulatory team meetings to support anticipated promotional messages and claims in clinical trial design and product labeling.
Maintain current awareness of FDA advisory correspondence, evolving regulations and guidance, enforcement letters, and policy issues affecting the pharmaceutical and biologics industries, and articulate regulatory rationale.
Take on complex projects and provide promotional regulatory training and coaching to team members.
Contribute to departmental strategic initiatives to drive effective, compliant promotional regulatory review.