Associate Director, Regulatory Affairs - Advertising & Promotion

Role Summary

The Associate Director US Regulatory Affairs - Advertising & Promotion plays a key role within the Regulatory Affairs organization and is responsible for ensuring promotional and non-promotional materials meet the regulatory requirements with US and other health agency laws and regulations. This role upholds regulatory standards, adheres to company policies, and aligns with industry guidelines while managing the review and approval of materials and projects.

In this capacity, the Associate Director collaborates closely with cross-functional partners, including Medical Affairs, Legal/Compliance, and Marketing. The position provides regulatory review for promotional and medical content as part of the Promotional Review Committee (PRC) and Medical Review Committee (MRC), ensuring timely delivery of high-quality materials and consistency across all communications.

Responsibilities

• Participate in review meetings providing regulatory input on promotional and non-promotional materials. Medical Materials may include medical slides, medical training materials, medical education materials, and others. 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 includes 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‚Äôs OOPDP, 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‚Äôs degree (required) in Life Sciences or a related discipline from an accredited four-year institution. An advanced degree preferred.
• >8 years of experience in pharmaceutical or biotech setting, including at least 5 years 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 success in leadership, mentoring, and training experience within theadvertising/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.

Skills

• Curiosity: Keep on exploring uncharted territories. Always ask ‚Äúwhy?‚Äù and more importantly ‚Äúwhy not?‚Äù,
• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,
• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,
• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.