Manager Regulatory Affairs, Advertising & Promotion (Remote)

Discover your role

• Management of US regulatory activities associated with advertising and promotion of the company's marketed products.
• Manages commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director.
• Creatively contribute and advise on the development of product messages and materials across multiple functional areas.
• Provide timely regulatory advice and guidance to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
• Provide review of US and Global product and disease state materials/communications to support company goals and adhere to applicable laws, regulations, and guidance.
• Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
• Establish working relationship 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 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 and provide stakeholders with updates.
• Identify process improvement for promotional review activities enabling portfolio-wide standardization of policies.
• Cross train across products/indications to ensure continuous Regulatory A&P support.
• Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
• Provide input during review cycles to reflect commercialization objectives and messages in submission documents/reports.
• Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

This role requires

• A minimum of 2 total years relevant experience, preferably within Regulatory Advertising and Promotion.
• At minimum, a Bachelor's degree from an accredited college or university in Life Sciences. An Advanced Scientific degree is preferred.
• 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.
• Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred.
• Ability to review promotional materials and interact with FDA OPDP/APLB and support 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 work collaboratively with colleagues at all levels.
• Ability to interact with senior management if needed.