Manager/Senior Manager, Regulatory Affairs Advertising and Promotion

Axsome Therapeutics, Inc.•New York, NY

44d•$125,000 - $145,000•Onsite

About The Position

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X. About This Role Axsome Therapeutics is seeking a Manager/Senior Manager, Regulatory Affairs Advertising and Promotion who will be responsible for providing regulatory guidance on promotional and non-promotional communications to ensure compliance with FDA regulations and internal standards. This individual will work with Regulatory Advertising and Promotion leadership to support the strategic execution of the company's promotional regulatory activities and collaborate closely with cross-functional partners, including Marketing, Medical Affairs, Legal, and Commercial Operations. This role will also supports the submission of materials to the FDA. This position 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. We are unable to consider candidates who are looking for fully remote roles.

Requirements

Bachelor's degree in life sciences or related field required. Advanced academic qualifications/degree such as Pharm.D. or Ph.D.
Manager: A minimum of 3-5 years in the pharmaceutical industry with at least 2 years in Regulatory Affairs with a focus on US Advertising and Promotion
Senior Manager: A minimum of 5-7 years in the pharmaceutical industry with at least 3 years in Regulatory Affairs with a focus on US Advertising and Promotion
Ability to travel up to 10%
Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles

Nice To Haves

Experience working with Veeva PromoMats or similar review systems preferred
Strong attention to detail and excellent organization skills
Proven aptitude for analyzing and interpreting scientific data
Demonstrated ability to negotiate, influence without authority, and problem solve in a cross-functional team
Strong interpersonal skills and communication skills (both written and oral)
Comfortable multi-tasking in a fast-paced, small company environment and able to adjust workload based upon changing priorities

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 both are compliant with relevant laws, regulations, guidance documents, and internal policies related to the proper use and safety of products
Support the submission of promotional materials to FDA for post marketing requirements and advisory comment as needed
Work with Ad/Promo leadership to monitor, interpret, and communicate relevant FDA enforcement actions, policy updates, and guidance documents; assess and communicate impact to promotional activities and strategy
Collaborate with cross-functional teams to proactively identify and mitigate regulatory risks while enabling timely and compliant communication strategies
Propose creative solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk
Identify areas of potential regulatory compliance vulnerability and risk; develop/collaborate on corrective measures
Work with Ad/Promo leadership to communicate and manage timing and strategy of revisions to promotional labeling and advertising based on planned or unplanned changes to product labeling, advisory comments, enforcement, or FDA guidance documents
Assist in the development of 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