Manager, Regulatory Affairs, Advertising & Promotion

Regeneron is hiring a Manager, Regulatory Affairs, Advertising & Promotion to oversee regulatory activities for advertising and promotion of marketed products. The role advises commercial and medical teams, reviews product and disease-state communications, supports FDA interactions and submissions, and helps ensure promotional materials meet applicable requirements.

Responsibilities

• 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 to the advise on the development of product messages and materials across multiple functional areas
• Provide timely regulatory advice and guidance, with 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 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; in partnership with management, provide guidance to stakeholders with respect to impact of enforcement activities on the company policies
• Ability to identify process improvement for promotional review activities that would enable the 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 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

Preferred

• preferably within Regulatory Advertising and Promotion
• An Advanced Scientific degree (i.e., Masters, PharmD, Ph.D)
• biologics experience is a plus
• Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred
• Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations is desirable
• Regulatory Advertising
• Promotion
• Advanced Scientific Degree
• Biologics Experience
• FDA Experience
• OPDP/APLB Experience
• Global Promotional Review
• Clinical Trial Recruitment Materials
• Labeling Regulations

Benefits

• Depending on country and role, annual bonuses or other incentive plans
• Depending on country and role, equity awards
• Depending on country and role, pension or retirement benefits
• Depending on country and role, 401(k) company match
• Depending on country and role, health and wellness programs
• Depending on country and role, fitness centers
• Depending on country and role, insurance benefits (e.g. medical, dental, vision, life and disability)
• Depending on country and role, paid time off
• Depending on country and role, family support benefits

Company

• Develops and commercializes biopharmaceutical medicines for serious diseases
• Tarrytown, New York, USA
• http://www.regeneron.com/
• Founded in 1988
• 10001+ employees

Qualifications

• A minimum of 2 total years relevant experience
• At minimum, a Bachelor's degree (BS) from an accredited college or university in Life Sciences
• 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
• 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
• Preferably within Regulatory Advertising and Promotion
• An Advanced Scientific degree (i.e., Masters, PharmD, Ph.D)
• Biologics experience is a plus
• Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred
• Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations is desirable

Required skills

• Pharmaceutical Advertising and Promotion Regulations, Pharmaceutical Product Development and Marketing, Pharmaceutical Products, FDA OPDP/APLB, Promotional Material Review, Global Promotional Review, Clinical Trial Recruitment Materials, Pharmaceutical Labeling Regulations, Biologics

Preferred skills

• preferably within Regulatory Advertising and Promotion, An Advanced Scientific degree (i.e., Masters, PharmD, Ph.D), biologics experience is a plus

Experience

• 2+ years