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Director, Regulatory Affairs, Advertising & Promotion (Remote)

Remote · United States Full-time

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking Director, Regulatory Affairs Advertising & Promotion Global to join our Regulatory Affairs team, supporting our global development and commercial business in a hybrid work model. In this role, you will lead advertising and promotion regulatory strategy, shape product messaging, and support compliant commercialization activities while collaborating with Commercial, Medical Affairs, Legal, and Regulatory stakeholders. 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: Remote - United States Remote:5 days per week on site Discover your role: Lead US and global regulatory activities supporting advertising, promotion, and commercialization initiatives. Advise on product messaging and promotional materials across functional areas. Provide regulatory guidance for conference exhibits, disease awareness, and speaker programs. Review promotional and disease-state communications for compliance with applicable requirements. Partner with Marketing, Medical Affairs, Legal, and Regulatory Therapeutic Area Leads. Oversee FDA promotional interactions, advisory submissions, and Form 2253 compliance. Drive process improvements and portfolio-wide promotional policy standardization. You build trusted relationships that influence decisions across complex stakeholder groups. This role requires: Master's, PharmD, or PhD; or a Bachelor's degree in Life Sciences from an accredited institution. Minimum 7 years of biotechnology or pharmaceutical industry experience. Deep expertise in advertising and promotion regulations, guidance, and development precedents. Experience supporting pharmaceutical products; biologics experience is a plus. Experience working directly with FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB). Experience reviewing promotional materials and supporting product launches or campaigns.

  • Knowledge of commercialization strategy, labeling development, and marketing application content.

Experience with global promotional review, clinical trial recruitment materials, and labeling regulations preferred. Experience leading teams, influencing cross-functional stakeholders, and working with senior management. Strong written and verbal communication skills for strategic regulatory guidance. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter. Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position. Salary Range (annually) $205,000.00 - $341,600.00

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