Manager, Regulatory Affairs - Advertising & Promotion Job at BioSpace in Village

Overview

Regeneron is seeking a Manager, Advertising and Promotion to join our Regulatory Affairs team. This role focuses on applying clinical development knowledge with an understanding of advertising and promotion regulations to develop key product messages for BLAs and MAAs, and to provide regulatory advertising and promotion expertise to stakeholders.

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 advice 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.
• Identify opportunities for process improvement in promotional review activities to enable portfolio-wide standardization of policies.
• Cross-train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders.
• Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
• With guidance from management, provide input during review cycles to reflect commercialization objectives and messages in submission documents/reports 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

• A minimum of 2 to 3 years within regulatory affairs, preferably within advertising and promotion, or completion of a Post-Doctoral Fellowship Program focused on Regulatory Affairs, including Advertising and Promotion with 1-year work-related experience.
• Requires advanced scientific degree (i.e., Masters, PharmD, Ph.D) or at minimum, a Bachelor's degree (BS) in Life Sciences.
• Knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in 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 when giving strategic regulatory advice.
• Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations is desirable.
• Contributes to the influence of cross-functional teams and may interact with senior management.

Salary Range (annually): $126,700.00 - $206,900.00

Location: Stamford, CT (as applicable to the posting)

Equal Employment Opportunity statement: Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveller community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. Reasonable accommodation will be provided to known disabilities or chronic illnesses of otherwise qualified applicants unless such accommodation would impose undue hardship on operation of the business.

Please note: Background checks may be part of the recruitment process and will be conducted in accordance with local law.