The Associate Director, Regulatory Affairs Advertising and Promotion requires the ability to apply clinical development knowledge in concert with experienced understanding of Ad/Promo regulations/guidance to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs).
We believe you would provide expertise to relevant partners, typically carrying out the responsibilities autonomously. We assume the Associate Director will work on Oncology and ensure that messages are translated into advertising and promotion initiatives that meet the commercial teams 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 companys marketed products, as well as commercial development of pipeline products. Manages commercial activities from a regulatory advertising and promotion perspective with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director.
- Creatively advise on the development of product messages and materials across multiple functional areas.
- Provide timely regulatory advice and guidance, with minimal 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 minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to support company goals and align with applicable laws, regulations, and guidance.
- 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.
This role might be for you if:
- You demonstrate solid understanding of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion
- You have worked directly/indirectly with FDA specifically OPDP/APLB
- You can work on global program and support the review process
To be considered, we are looking for applicants to have a Masters, PhD or PharmD degree along with 7+ years of shown experience focused on advertising and promotion within a pharmaceutical company. We also expect individuals to be able to come to our Sleepy Hallow and Tarrytown offices a couple days a week.
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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$165,900.00 - $270,700.00