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

Overview

Senior Manager, Regulatory Affairs Advertising & Promotion – BioSpace. The Senior Manager position within the Regulatory Affairs department applies clinical development knowledge with expertise in advertising and promotion regulations/guidance to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). They provide regulatory advertising and promotion expertise to stakeholders, typically with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director. The Senior Manager oversees therapeutic area(s) and ensures that messages are translated into advertising and promotion initiatives that meet commercial objectives while maintaining compliance and corporate integrity.

In This Role, a Typical Day Might Include

Lead US and Global (if applicable) regulatory activities related to advertising and promotion of marketed products and the commercial development of pipeline products. Advise on the development of product messages and materials across multiple functions. Provide timely regulatory guidance to Commercial teams and Medical Affairs on conference exhibits, disease awareness, and speaker programs. Review US and Global product and disease-state materials to support corporate goals and ensure compliance with applicable laws, regulations, and guidance. Collaborate cross-functionally with Marketing, Medical Affairs, and Legal. Establish and manage communication with regulatory advertising and promotion professionals at co-promote partner companies. Help lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) and maintain effective communication with FDA reviewers. Ensure compliance with promotional material submissions to FDA on Form 2253. Monitor regulatory environment and advise product teams on evolving requirements. Maintain vigilance on FDA promotional enforcement activities and provide updates to stakeholders. Contribute to process improvement for promotional review activities and standardization of policies. Cross-train across products/indications to maintain ongoing Regulatory A&P support. Review key marketing application documents and study reports with Regulatory Therapeutic Area Leads. Provide input during submission reviews to reflect commercialization objectives and messages. Contribute to labeling development and negotiation to reflect commercialization objectives for promotion and advertising.

Qualifications & Experience

• Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred
• Ability to review promotional materials and interact with FDA OPDP/APLB, while providing strategic regulatory advice with strong written/verbal communication
• 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
• Minimum 3 to 4 years within regulatory affairs, preferably within advertising and promotion
• At minimum, a Bachelor’s degree (BS) in Life Sciences; advanced degree (Masters, PharmD, PhD, MD, or DO) preferred; regulatory experience can offset education requirements
• Advanced knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, focusing on advertising and promotion
• Experience with pharmaceutical products required; biologics experience is a plus

Salary & Location

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

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Legal (note: role aligns with regulatory affairs advertising & promotion responsibilities as described)

Industries: Internet News

Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture with comprehensive benefits and opportunities for growth. Regeneron is an equal opportunity employer. Background checks may be conducted in accordance with applicable laws.