Associate Manager, Regulatory Advertising & Promotion

The Associate Manager 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). Provides regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs, Advertising and Promotion Director. The Associate Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) and ensure that messages are translated into advertising and promotion initiatives that meet the commercial team’s objectives, while maintaining the necessary state of compliance and corporate integrity.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Work Location: Sleepy Hollow, NY or Warren, NJ

• Hybrid; 4 days per week on site

Discover your role:

• Contribute to the 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.

• Contribute to the advise on the development of product messages and materials across multiple functional areas.

• Assist with providing 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

• Assist with providing 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.

• Ability to collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.

• Contributes to the working relationship and managing communication with regulatory advertising and promotion professionals at co-promote partner companies

• Assist with interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, assist with 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; help assess the potential impact of enforcement activities on the company policies.

• Knowledge of process improvement for promotional review activities that would enable the establishment of portfolio wide standardization of policies

• Knowledge of products/indications to help provide 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

• Knowledge of the input provided during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities

• Ability to understand and work with management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

This role requires:

• A minimum of 1 to 2 years within regulatory affairs, preferably within advertising and promotion or completion of a Post-Doctoral Fellowship Program with related experience focused on Regulatory Affairs, including Advertising and Promotion

• Requires advanced scientific degree (i.e., Masters, PharmD, Ph.D) or at minimum, a Bachelor's degree (BS) from an accredited college or university in Life Sciences.

• Fundamental understanding 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 is highly preferred, biologics experience is a plus

• Experience working directly/indirectly with the FDA, specifically OPDP/APLB is desirable

• Ability to review promotional materials and interact with FDA OPDP/APLB and help support launch products/campaigns, while maintaining excellent written/verbal communication skill

• Familiarity with global promotional review, clinical trial recruitment materials, and labeling regulations is desirable

• Contributes to the influence of cross-functional teams and may interact with senior management

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Salary Range (annually)