Associate Director, Regulatory Affairs, Advertising & Promotion

Role Summary

Regeneron's Regulatory Affairs Organization is seeking an Associate Director to join the Advertising & Promotion team. This role applies clinical development knowledge with advertising and promotion regulations to develop key product messages for regulatory submissions such as BLAs and MAAs, and to guide promotional activities in line with regulatory and corporate objectives.

Responsibilities

• Manage US and Global regulatory activities associated with advertising and promotion of the company’s marketed products, as well as commercial development of pipeline products.
• Independently manage commercial activities from a regulatory advertising and promotion perspective.
• Creatively advise on the development of product messages and materials across multiple functional areas.
• Independently provide regulatory advice and guidance to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
• Independently provide review of US and Global (if applicable) product and disease state materials/communications 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
• 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
• Provide input during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities
• Provide input during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

Qualifications

• A minimum of 5 total years relevant experience, preferably within Regulatory Advertising and Promotion
• Experience with pharmaceutical products required, biologics experience is a plus
• Experience working directly with the FDA, specifically OPDP/APLB is required
• 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
• Experience with global promotion reviewal, clinical trial recruitment materials, and familiarity with labeling regulations is preferred
• Proven ability to lead and influence cross-functional teams and work effectively with senior management

Education

• Bachelor's degree (BS) in Life Sciences from an accredited college or university
• Advanced scientific degree (Masters, PharmD, Ph.D) preferred

Additional Requirements

• This position has a 4 day (weekly) onsite requirement based out of Sleepy Hollow, NY.