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Axsome Therapeutics, Inc. · 1 day ago

Manager/Senior Manager, Regulatory Affairs Advertising and Promotion

New York, NY

Full-time

Hybrid

Mid, Senior Level

$125K/yr - $145K/yr

3+ years exp

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of CNS conditions. They are seeking a Manager/Senior Manager in Regulatory Affairs Advertising and Promotion to provide regulatory guidance on promotional communications, ensuring compliance with FDA regulations and collaborating with cross-functional teams.

BiopharmaBiotechnologyTherapeutics

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

Qualification

Regulatory AffairsUS AdvertisingPromotionVeeva PromoMatsScientific Data AnalysisInterpersonal SkillsCommunication SkillsAttention to DetailProblem SolvingOrganizational Skills

Required

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

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