Senior Manager, Regulatory Advertising & Promotion

This position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). We expect you will ensure that messages are translated into advertising and promotion initiatives that meet the commercial team's objectives, while maintaining the vital state of compliance and corporate integrity.
In this role, a typical day might include the following:

Management of US and Global regulatory activities associated with advertising and promotion of the company's marketed products, as well as commercial development of pipeline products.

Creatively advise on the product messages and materials across multiple functional areas.

Provide regulatory advice and guidance to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.

Review and approve US and Global product and disease state materials/communications to support corporate goals and align with applicable laws, regulations, and guidance.

Collaborate cross functionally with key partners in areas such as Marketing, Medical Affairs, and Legal.

We need you to establish working relationship and lead communication with regulatory advertising and promotion professionals at co-promote partner companies.

Assist in all FDA interactions with the Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers for advertising and promotion matters, including pre-clearance of materials.

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 partners with updates on a regular basis; provide guidance to partners regarding the impact of enforcement activities on the company policies.

Provide input to key partners regarding process improvement for promotional review activities and establishment of portfolio wide standardization of policies.

Cross train across products to ensure continuous Regulatory A&P support is provided to partners.

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 to reflect commercialization objectives and messages that impact promotion and advertising.
This role might be for you if:

• Requires advanced scientific degree (i.e., Masters, PharmD) with a minimum of 3-5 years within regulatory affairs, reviewing promotional materials and interacting with OPDP/APLB and leading launch campaigns
• Extensive 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
• We like experience working with the FDA, specifically OPDP/APLB
• Must possess excellent written/verbal communication skills
• Shown ability to influence cross-functional teams and work effectively with senior management
• We seek familiarity with labeling regulations
• Experience with global promotion review and clinical trial recruitment materials is a plus

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

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 Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.