Associate Director Regulatory Advertising & Promotion

Location
Tarrytown, New York
Posted
May 09, 2022
Ref
REGEA0026R10798
Required Education
Bachelors Degree
Position Type
Full time

The Associate Director 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 independently. The Associate Director 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.

In this role, a typical day might include the following:

* Management of US and Global (if applicable) regulatory activities associated with advertising and promotion of the company’s marketed products, as well as commercial development of pipeline products. Manages commercial activities from a regulatory advertising and promotion perspective independently.

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

* Independently provide timely 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 training 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.

This role might be for you if:

* A minimum of 5 to 7 years within regulatory affairs, preferably within 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.

* Expert 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

* 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 promotional review, 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

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.