Senior Manager, Regulatory Affairs Advertising & Promotion Job at BioSpace in Vi

Overview

Senior Manager, Regulatory Affairs Advertising & Promotion. 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 teams objectives, while maintaining the necessary state of compliance and corporate integrity.

Responsibilities

• 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.
• Establish working relationships and manage 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, including maintaining working relationship and effective communication with FDA OPDP reviewers regarding advertising and promotion matters, including requests for advisory submissions.
• Ensure 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 updates to stakeholders and guidance on impact of enforcement on company policies.
• Contribute to process improvement for promotional review activities and help establish portfolio-wide standardization of policies.
• Cross-train across products / indications to ensure continuous Regulatory A&P support for stakeholders.
• Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
• With minimal guidance from management, provide input during review cycles to reflect commercialization objectives and messages in submission documents / reports 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

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

Salary and location

Salary Range (annually) : $148,300.00 - $241,900.00

Locations mentioned : Elmwood Park, NJ; Stamford, CT; Montvale, NJ; Secaucus, NJ.

Job details and related roles

About the employer

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 in 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 the U.S., salary ranges are shown according to U.S. law and apply to U.S.-based positions. For roles based in Japan and / or Canada, ranges follow 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 and will be conducted in accordance with the law of the country where the position is based.

Salary Range (annually) : $148,300.00 - $241,900.00

Does this sound like you? Apply now to take your first step towards living the Regeneron Way!

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