Job ID: 7760
Job Title: Director,US Regulatory Advertising & Promotion
Location: Somerset County, NJ
Our client is a global, clinical-stage biopharmaceutical organization focused on developing innovative therapies for immunologic diseases with significant unmet medical needs. They are seeking a Director, US Regulatory Advertising & Promotion to join their growing Regulatory Affairs organization.
Position: This is a high-impact opportunity for a regulatory leader to shape and oversee US promotional regulatory strategy in a dynamic, fast-growing environment. In this role, you will be responsible for ensuring that promotional and non-promotional materials comply with US FDA regulations and align with broader regulatory, medical, and commercial objectives.
This is an exceptional growth opportunity to join a mission-driven team pioneering next-generation therapies for patients worldwide and to play a vital role in bringing transformative treatments to market.
Key Responsibilities:
- Participate in review meetings and provide regulatory input on promotional and non-promotional materials. Medical Materials may include medical slides, training materials, educational materials, and more. Promotional/Marketing Materials may include advertising materials, speaker training materials, Commercial advisory board materials, peer-reviewed publications, and others.
- Collaborate with material owners, reviewers, and key internal partners to ensure alignment across assigned projects/materials. Key internal partners include Medical, Legal, Compliance, Marketing, and Commercial.
- Represent Regulatory Affairs in Functional and Operational Meetings as it pertains to the Promotional or Medical Review Process and Best Practices.
- Prepare and review submissions seeking regulatory advice, support the resolution of FDA action letters, and lead company interactions with FDA Office of Prescription Drug Promotion (OPDP) and other health authorities.
- Ensure consistency with prescribing information and safety information.
- Ensure standardization of defined policies, SOPs, and best practices, and provide feedback and recommendations to optimize these processes and workflows.
- Coordinate and deliver ongoing company-wide regulatory training related to promotional requirements for company products.
- Participate in training programs for internal stakeholders, including specifically Medical Affairs staff, to ensure best practices, up-to-date knowledge, and operational excellence.
- Continuously monitor regulatory and compliance trends across the industry; analyze and interpret new regulations, guidance documents, and enforcement letters. Communicate updates on the evolving regulatory landscape, particularly within FDA’s OPDP, to Regulatory Affairs, review committees, and other relevant stakeholders; develop or update procedures as needed.
- Support Regulatory Affairs with additional projects, as needed.
- Collaborate regularly with Legal, Compliance, and Medical Affairs; work with Quality on internal audits and CAPA activities as required.
Qualifications:
- Bachelor’s degree in Life Sciences or a related discipline from an accredited four-year institution. An advanced degree is preferred.
- 10+ years of experience in a pharmaceutical or biotech setting.
- 5+ years of hands-on experience focused specifically on advertising and promotion.
- Working knowledge of US, EU, and Canadian health agency regulatory standards
- Well-versed in scientific and clinical trial knowledge, documents, and vocabulary
- Proficiency in Microsoft Office applications required; knowledge of Veeva systems desirable
- Demonstrated leadership success, mentoring, and training experience within the advertising/promotion function of Regulatory Affairs is required.
- Strong understanding of complex medical and scientific concepts, including statistical data.
- Proven ability to build effective networks and influence outcomes without formal authority, including within cross-functional teams (Medical, Legal, Regulatory, etc.) and working with the Regulatory authorities at FDA (and globally a plus).
- Creative problem-solving skills, with the ability to explore novel approaches to challenges and opportunities.
- Strong interpersonal skills with the ability to adapt communication style to gain alignment and acceptance of ideas or recommendations.
- Exceptional organizational skills with the ability to prioritize, manage multiple tasks simultaneously, and meet timelines independently.
- High level of integrity, with a commitment to accurate and transparent representation of information and data.
