Executive Director, Regulatory Affairs

Merck • North Wales, PA

2d • Hybrid

About The Position

This position will be responsible for the leadership, oversight and direction for the regulatory review function of US advertising and promotion. This role has ad/promo regulatory review accountabilities across all Therapeutic Areas of our company's portfolio in the U.S. This role will manage a team of reviewers and supporting roles to set the strategic direction for a staff of 30+ professionals. This executive leadership position has Strategic Responsibilities: Regulatory Guidance: Interpret and apply advertising and promotion regulations in reviews. Proactively design risk mitigation that anticipates the evolving regulatory landscape and allows for aggressive yet compliant promotional campaigns. FDA Representation: Act as the primary liaison to the FDA's Office of Prescription Drug Promotion (OPDP) and FDA’s Advertising and Promotional Labeling Branch (APLB), including leading negotiations, interpretations of complex regulations and shaping the dialogue surrounding novel promotional strategies. Integrated Commercial Strategy Partnership: Function as a partner, providing consultative leadership to cross-functional executive teams (Commercial, Medical and Legal). Ensure seamless integration between regulatory strategy and commercial objectives, ensuring launch and post-approval materials are strategically optimized for market impact from day one. Advise and educate commercial, regulatory, legal, and compliance on regulatory standards, policies and processes for development, review, approval, and dissemination of marketing and promotion materials to ensure they are of the highest quality and are fully compliant with the letter and spirit of relevant laws, FDA regulations and guidance, PhRMA and other industry guidelines, and our company's policies and guidelines. Leadership & Organizational Development: Build and maintain a high-performing team that consistently demonstrates the value of authoritative regulatory guidance on advertising and promotion. Develop and maintain a staffing model and resource algorithm that ensures appropriate and effective resources to meet business objectives and priorities. Monitor and oversee staff to ensure they are trained on and compliant with all applicable federal health care program requirements, FDA requirements, obligations relevant to any government settlements such as any Corporate Integrity Agreement and/or Consent Decrees and our company policies related to advertising and promotion. Develop and maintain our company's relationship of trust and respect with FDA OPDP and APLB through constructive, productive, and transparent communications. Increase the external impact and influence of our company on shaping regulatory science for the industry by contributing to key discussions and interfacing with professional organizations, consortia, academics, and government agencies on issues related to advertising and promotion.

Requirements

• Minimum of 15 years biopharmaceutical industry experience in functions of compliance, regulatory strategy, and/or promotion development, with a strong focus on the US review of advertising and promotional materials
• Minimum of 8 years direct experience in reviewing US prescription drug/biologic advertising and promotion materials and marketing programs for regulatory/legal compliance
• Recognized expert in US regulatory advertising and promotion requirements; Demonstrated subject matter expertise in advertising and promotion of FDA-regulated products, including product launches and digital promotion
• In-depth understanding of the clinical development process, including labeling development
• Experience in leading teams and effectively managing staff; At least 5 years managing individual contributors
• Superior skill in analyzing complex regulatory/legal issues and evaluating alternatives and determining risk
• Proven leadership and management skills with cross-functional teams, as well as inspiration and motivational skills
• Superior negotiation and influencing skills, with a proven track record of critical, strategic, independent thinking and problem -solving
• Decisions and actions are always in the best interests of patients, customers and our company and never superseded by organizational politics
• Must have high level of motivation, drive, and demonstration of our company's leadership values
• Excellent written and verbal communication skills, including the ability to write clearly and concisely
• Top-notch interpersonal skills in difficult situations; Ability to work seamlessly with all levels of personnel
• Change Management: Effectively implements procedures or makes decisions to deal with change. Copes with ambiguity in the business environment and leads effectively through ambiguity to keep teams motivated and focused

Nice To Haves

• Advanced degree preferred.
• Strongly preferred to have a science-related degree such as biology, chemistry, nursing, pharmacy, social sciences, or QA/regulatory affairs.

Responsibilities

• Interpret and apply advertising and promotion regulations in reviews.
• Proactively design risk mitigation that anticipates the evolving regulatory landscape and allows for aggressive yet compliant promotional campaigns.
• Act as the primary liaison to the FDA's Office of Prescription Drug Promotion (OPDP) and FDA’s Advertising and Promotional Labeling Branch (APLB), including leading negotiations, interpretations of complex regulations and shaping the dialogue surrounding novel promotional strategies.
• Function as a partner, providing consultative leadership to cross-functional executive teams (Commercial, Medical and Legal).
• Ensure seamless integration between regulatory strategy and commercial objectives, ensuring launch and post-approval materials are strategically optimized for market impact from day one.
• Advise and educate commercial, regulatory, legal, and compliance on regulatory standards, policies and processes for development, review, approval, and dissemination of marketing and promotion materials to ensure they are of the highest quality and are fully compliant with the letter and spirit of relevant laws, FDA regulations and guidance, PhRMA and other industry guidelines, and our company's policies and guidelines.
• Build and maintain a high-performing team that consistently demonstrates the value of authoritative regulatory guidance on advertising and promotion.
• Develop and maintain a staffing model and resource algorithm that ensures appropriate and effective resources to meet business objectives and priorities.
• Monitor and oversee staff to ensure they are trained on and compliant with all applicable federal health care program requirements, FDA requirements, obligations relevant to any government settlements such as any Corporate Integrity Agreement and/or Consent Decrees and our company policies related to advertising and promotion.
• Develop and maintain our company's relationship of trust and respect with FDA OPDP and APLB through constructive, productive, and transparent communications.
• Increase the external impact and influence of our company on shaping regulatory science for the industry by contributing to key discussions and interfacing with professional organizations, consortia, academics, and government agencies on issues related to advertising and promotion.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

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