Senior Manager, Regulatory Affairs Advertising & Promotion

Role Summary

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.

Responsibilities

• Management of US and Global (if applicable) regulatory activities associated with advertising and promotion of the company‚Äôs 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.

Qualifications

• 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

Education

• A minimum of 3 to 4 years within regulatory affairs, preferably within advertising and promotion
• At minimum, a Bachelor‚Äôs 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