Associate Manager, Regulatory Affairs, Advertising & Promotion

Regeneron is seeking an Associate Manager, of Advertising and Promotion to join our Regulatory Affairs team!! In this role, a typical day might include: 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 role might be for you if you can/Have 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. To be considered for this opportunity, you must have the following: 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 #GDRAJobs Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $98,100.00 - $160,100.00