Associate Director, Regulatory Affairs - Advertising and Promotion

Merck•North Wales, PA

4d•$129,000 - $203,100•Hybrid

About The Position

The Associate Director is responsible for reviewing and approving all U.S. promotional materials and serving as the promotional regulatory expert to legal, medical, and commercial colleagues. The role ensures promotional practices are consistent with regulatory guidelines and company policies while supporting business objectives. The position serves as liaison with FDA promotional review divisions OPDP/APLB, including managing correspondence, complex regulatory questions, and submissions for advisory comment. It develops creative, effective, and compliant regulatory strategies for challenging promotional concepts, provides regulatory consultation on U.S. marketing strategies and promotional programs, and supports commercial teams with guidance on marketing strategy, promotion objectives, and tactics. The Associate Director participates in labeling and global regulatory team meetings to support anticipated promotional messages and claims through clinical trial design and product labeling. The role also maintains awareness of FDA correspondence, regulations, guidance, enforcement letters, and policy issues; provides regulatory training and coaching; takes on complex projects; and contributes to departmental initiatives to improve effective, compliant promotional review. This is a hybrid position requiring onsite work three days per week in Upper Gwynedd, Pennsylvania, or Rahway, New Jersey. The role requires 10% travel. The employee is eligible for an annual bonus and long-term incentive, if applicable. Relocation is not offered, and visa sponsorship is not available.

Requirements

B.A. or B.S. 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.
Excellent verbal and written communication skills.
Attention to detail and ability to manage multiple priorities simultaneously.
Strong interpersonal skills and the 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.
Willingness to travel 10%.

Nice To Haves

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

Responsibilities

Review and approve all U.S. promotional materials.
Serve as the promotional regulatory expert and collaborate with legal, medical, and commercial colleagues to ensure compliance with regulatory guidelines and company policies while supporting business objectives.
Serve as liaison with FDA promotional review divisions OPDP/APLB and manage related correspondence, complex regulatory questions, and submissions for advisory comment.
Develop compliant regulatory strategies and solutions for challenging promotional concepts that meet business objectives and minimize regulatory risk.
Provide regulatory consultation for U.S. marketing strategy and promotional program development and implementation.
Support U.S. commercial teams by participating in strategy discussions and extended team meetings and providing regulatory guidance on marketing strategies, promotion objectives, and tactics.
Provide regulatory input on concepts and draft materials to ensure 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.
Monitor FDA advisory correspondence, regulations, guidance documents, enforcement letters, and relevant policy issues, 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.