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

MSD • 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 a promotional regulatory expert to legal, medical, and commercial colleagues. The role ensures promotional practices align with regulatory guidelines and company policies while supporting business objectives, and operates at an advanced and independent level.

The Director manages FDA promotional review division correspondence, including complex regulatory questions and advisory-comment submissions; develops creative, compliant strategies for challenging promotional concepts; and partners across review, compliance, and commercial teams to maintain an integrated regulatory strategy from early development through approval and marketing. The role leads promotional regulatory strategy for assigned products, including rationale for Global Target Product Information (GTPI), and addresses promotional considerations in clinical trial design and product labeling.

The position requires expert knowledge of FDA advertising and promotion regulations, the PhRMA Code and Principles, and company policies. The Director provides leadership, training, coaching, and mentoring to colleagues and leads departmental initiatives to improve effective and compliant promotional regulatory review.

Requirements

• B.A. or B.S. 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.
• Strong strategic and analytical thinking capabilities and a demonstrated ability to build consensus.
• Effective collaboration with external stakeholders, including FDA branches (OPDP, APLB), alliance relationships with peer companies, 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 a promotional regulatory expert and advise legal, medical, and commercial colleagues.
• Manage correspondence and serve as liaison with FDA promotional review divisions OPDP/APLB, including complex regulatory questions and advisory-comment submissions.
• Develop creative, effective, and compliant regulatory strategies and solutions for challenging promotional concepts while minimizing regulatory risk.
• Partner with review, compliance, and commercial colleagues on integrated regulatory strategy from early development through approval and marketing.
• Lead assigned products’ promotional regulatory strategy, including the rationale for Global Target Product Information (GTPI).
• Address complex regulatory scenarios and promotional content.
• Identify solutions in labeling and global regulatory team meetings to support anticipated promotional messages and claims in clinical trial design and product labeling.
• Maintain expert understanding of FDA regulations governing advertising and promotion and provide compliant solutions consistent with FDA regulations, the PhRMA Code and Principles, and company policies and procedures.
• Support team members, take on complex projects, provide promotional regulatory training and coaching, and mentor new hires.
• Lead departmental strategic initiatives to drive effective, compliant promotional regulatory review.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays.
• Vacation.
• Compassionate and sick days.
• Eligible for annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Director