Senior Manager @ Regeneron Pharmaceuticals

Legal & Compliance (2)
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Legal & Compliance (2)

The Senior Manager position within the Regulatory Affairs department 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.

In this role, a typical day might include:

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.
Creatively advise on the development of product messages and materials across multiple functional areas.
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
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.
Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
Responsible for establishing working relationship and managing communication with regulatory advertising and promotion professionals at co-promote partner companies
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 request for advisory submissions.
Responsible for compliance with promotional material submissions to FDA on Form 2253
Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications
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.
Provide input to direct management with respect to process improvement for promotional review activities and establishment of portfolio wide standardization of policies
Ability to cross train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders
Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports
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
Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

This role might be for you if can/have the:

Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred
Ability to review promotional materials and interact with FDA OPDP/APLB and managing launch products/campaigns, while maintaining excellent written/verbal communication skill when giving strategic regulatory advice
Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations is desirable
Ability to influence cross-functional teams and interact with senior management

To be considered for this opportunity, you must have the following:

A minimum of 3 to 4 years within regulatory affairs, preferably within advertising and promotion
At minimum, a Bachelor’s degree (BS) from an accredited College or University in Life Sciences. Advanced degree (Masters, Pharm D, Ph.D., MD or DO) preferred in the field of medicine or science. Regulatory experience can offset education requirements.
Advance knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion
Experience with pharmaceutical products required, biologics experience is a plus

#GDRAJobs

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$148,300.00 - $241,900.00

Senior Manager

Regulatory Affairs Advertising & Promotion

Regeneron Pharmaceuticals

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