Manager/Senior Manager, Regulatory Affairs Advertising and Promotion

Role Summary

Manager/Senior Manager, Regulatory Affairs Advertising and Promotion responsible for providing regulatory guidance on promotional and non-promotional communications to ensure compliance with FDA regulations and internal standards. Collaborates with cross-functional partners and supports submission of materials to the FDA. Reports to the Executive Director, Regulatory Affairs Advertising and Promotion. This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week.

Responsibilities

• Serve as a core Regulatory reviewer on the Promotional Review Committee (PRC) for US advertising and promotional materials
• Independently review advertising and promotional labeling materials and internal communications to ensure compliance with laws, regulations, guidance documents, and internal policies related to product use and safety
• Support the submission of promotional materials to FDA for post marketing requirements and advisory comments as needed
• Monitor, interpret, and communicate relevant FDA enforcement actions, policy updates, and guidance documents; assess impact to promotional activities and strategy
• Collaborate with cross-functional teams to identify and mitigate regulatory risks while enabling timely and compliant communication strategies
• Propose creative solutions to promotional concepts that meet business objectives while minimizing regulatory risk
• Identify regulatory compliance vulnerabilities and develop/collaborate on corrective measures
• Communicate and manage timing and strategy of revisions to promotional labeling and advertising based on labeling changes, advisory comments, enforcement, or FDA guidance
• Assist in developing safety-related content in promotional materials, including the brief summary, ISI, and fair balance components
• Independently review medical materials and clinical trial recruitment materials as needed

Qualifications

• Bachelor‚Äôs degree in life sciences or related field required; advanced degrees such as Pharm.D. or Ph.D. preferred
• Manager: 3‚Äì5 years in pharmaceutical industry with at least 2 years in Regulatory Affairs focusing on US Advertising and Promotion
• Senior Manager: 5‚Äì7 years in pharmaceutical industry with at least 3 years in Regulatory Affairs focusing on US Advertising and Promotion
• Ability to travel up to 10%
• On-site work required: Monday, Tuesday & Thursday

Experience, Knowledge And Skills

• Experience with Veeva PromoMats or similar review systems preferred
• Strong attention to detail and excellent organization skills
• Aptitude for analyzing and interpreting scientific data
• Ability to negotiate, influence without authority, and solve problems in a cross-functional team
• Strong interpersonal and written/oral communication skills
• Ability to multi-task in a fast-paced, small company environment with changing priorities