Senior Manager, Regulatory Affairs, Advertising & Promotion

**Build Our Future Together**

At Regeneron, we use science and innovation to develop life‑changing medicines for people with serious diseases. We are seeking a Senior Manager to join our Regulatory Affairs Advertising and Promotion team. This position requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidance to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). They will provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs, Advertising and Promotion Director. The Senior Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) and ensure that messages are translated into advertising and promotion initiatives that meet the commercial team’s objectives, while maintaining the necessary state of compliance and corporate integrity.

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### When & where
Work Location: Sleepy Hollow, NY or Warren, NJ
4 days per week on site

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### Discover your role
– **Regulatory activities** — Management of US and Global (if applicable) regulatory activities associated with advertising and promotion of the company’s marketed products, as well as commercial development of pipeline products. Manages commercial activities from a regulatory advertising and promotion perspective with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director.

– **Product messaging** — Creatively advise on the development of product messages and materials across multiple functional areas.

– **Regulatory guidance** — Provide timely regulatory advice and guidance, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.

– **Material review** — Provide review of US and Global (if applicable) product and disease state materials/communications, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance.

– **Cross‑functional collaboration** — Collaborate cross‑functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.

– **Partner communication** — Responsible for establishing working relationships and managing communication with regulatory advertising and promotion professionals at co‑promote partner companies.

– **FDA OPDP interactions** — Help lead and assist in all interactions with the FDA Office of Prescription Drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including requests for advisory submissions.

– **Form 2253 compliance** — Responsible for compliance with promotional material submissions to FDA on Form 2253.

– **Regulatory monitoring** — Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications.

– **Enforcement vigilance** — Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; provide guidance to stakeholders with respect to impact of enforcement activities on the company policies.

– **Process improvement** — Provide input to direct management with respect to process improvement for promotional review activities and establishment of portfolio‑wide standardization of policies.

– **Cross‑training** — Ability to cross‑train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders.

– **Therapeutic area collaboration** — Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.

– **Submission input** — With minimal guidance from management, help provide input during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities.

– **Labeling development** — Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

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### This role requires
– **A minimum of 3 to 4 years** within regulatory affairs, preferably within advertising and promotion.
– **Bachelor’s degree (BS)** in Life Sciences; advanced degree preferred (Masters, PharmD, PhD, MD, DO). Regulatory experience can offset education requirements.
– **Advanced knowledge** of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in advertising and promotion.
– **Experience with pharmaceutical products** required; biologics experience is a plus.
– **Experience with FDA OPDP/APLB** preferred.
– **Ability to review promotional materials**, interact with FDA OPDP/APLB, and manage launch products/campaigns while maintaining excellent written/verbal communication skills.
– **Ability to support global promotional review**, understanding of clinical trial recruitment materials, and familiarity with labeling regulations.
– **Ability to influence cross‑functional teams** and interact with senior management.

#GDRAJobs

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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/]. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

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### Salary Range (annually)
$150,500.00 – $245,500.00

Apply here