Director, Regulatory Affairs, Promotion and Advertising Review (OPAR)

Merck•North Wales, PA

1d•$173,200 - $272,600•Hybrid

About The Position

The Individual Contributor Director reviews and approves U.S. promotional materials and serves as the promotional regulatory expert to legal, medical, and commercial colleagues. The role operates at an advanced and independent level, ensuring promotional practices align with regulatory guidelines and company policies while supporting business objectives. The Director manages correspondence with FDA promotional review divisions OPDP/APLB, including complex regulatory questions and submissions for advisory comment. The position develops promotional regulatory strategy for assigned products, including the rationale for Global Target Product Information (GTPI), and proposes creative, effective, compliant solutions to challenging promotional concepts while minimizing regulatory risk. The Director partners with review, compliance, and commercial colleagues to develop integrated regulatory strategy from early development through approval and marketing. The role contributes to labeling and global regulatory discussions so clinical trial design and product labeling support anticipated U.S. promotional messages and claims. It requires expert knowledge of FDA advertising and promotion regulations, the PhRMA Code and Principles, and company policies and procedures. The Director is also expected to lead and mentor colleagues, provide promotional regulatory training and coaching, and develop departmental strategic initiatives to improve effective and compliant promotional regulatory review.

Requirements

Bachelor of Arts or Bachelor of Science degree with an emphasis in science, health care, or a related field.
At least 10 years of pharmaceutical/biologics industry or related experience emphasizing regulatory or scientific disciplines.
At least 5 years of direct experience as the primary reviewer of advertising and promotional materials.
In-depth understanding of FDA regulations and company policies and procedures related to promotion development, implementation, and review processes.
Strong diplomacy, interpersonal, and negotiation skills.
Strategic and analytical thinking capabilities and a demonstrated ability to build consensus.
Track record of effective collaboration with external stakeholders, including FDA branches (OPDP, APLB), peer-company alliance relationships, and external consortia and trade organizations such as DIA.
In-depth understanding of clinical development, regulatory policy, labeling development, and FDA approval processes.
Ability to identify solutions to complex promotional regulatory issues.
Superior verbal and written communication skills.
Skills in advertising compliance, communication, cross-functional teamwork, attention to detail, FDA regulations, negotiation, pharmaceutical advertising, the PhRMA Code, policy implementation, problem solving, regulatory affairs, regulatory risk, regulatory strategies, strategic thinking, and team collaboration.

Nice To Haves

Master’s, PhD, or PharmD degree with an emphasis in science, health care, or a related field.

Responsibilities

Review and approve U.S. promotional materials.
Serve as the promotional regulatory expert for legal, medical, and commercial colleagues.
Liaise with FDA promotional review divisions OPDP/APLB and manage correspondence, including complex regulatory questions and submissions for advisory comment.
Develop creative, effective, and compliant regulatory strategies and solutions for challenging promotional concepts while minimizing regulatory risk.
Partner with the review team, compliance, and commercial colleagues on an integrated regulatory strategy from early development through approval and marketing.
Lead promotional regulatory strategy development for assigned products, including the rationale for Global Target Product Information (GTPI).
Identify solutions during labeling and global regulatory team meetings to support anticipated promotional messages and claims through clinical trial design and product labeling.
Apply expert knowledge of FDA advertising and promotion regulations, the PhRMA Code and Principles, and company policies and procedures to address regulatory and commercial needs compliantly.
Provide promotional regulatory training and coaching, mentor new hires, and support team members.
Lead development of departmental strategic initiatives to drive effective, compliant promotional regulatory review.