PharmD Program Associate - Regulatory Labeling & Advertising/Promotion
About The Position
The PharmD Program is an intensive, interdisciplinary program for graduating PharmD and/or PhD candidates. The program consists of training by Regeneron mentors and experience leading projects in various global development roles. This unique program provides participants depth and breadth of experience within Regeneron's Global Development organization. Participants will acquire technical and non-technical skills throughout the program through diverse training, cross-functional experiences, and ongoing mentorship. Assignments in this 2-year development program will expose candidates to critical issues and decision-making processes, acquire high-level knowledge of the business and department operations, and gain hands-on work experience in different areas. The program is comprised of a 24-month rotational experience within one of the following tracks: Clinical Operations & Program Management, Clinical Sciences, Regulatory Strategy, Regulatory Labeling & Advertising/Promotion, Safety Sciences. Associates will also have opportunities to gain exposure to a different functional area through an optional elective rotation as a part of the 24-month program. Specifically, the Regulatory Labeling & Advertising/Promotion track involves contributing to the development of labeling content and labeling strategies through interpretation of regulations and guidelines; supporting the labeling process throughout the product lifecycle, including Labeling Working Group reviews and management approvals; developing knowledge and skills to interpret FDA regulations and guidances to ensure promotional communications are truthful and not misleading; appropriately advising teams on associated regulatory risks; and supporting FDA-Office of Prescription Drug Promotion (OPDP) interactions.
Requirements
- Post-doctoral graduates from an accredited (ACPE) College of Pharmacy program (PharmD); PhD graduates within a life science related area of study may also be considered.
- Must have completed PharmD and/or PhD degree by Summer 2027
- Eligible to work in the U.S. on a permanent basis
Nice To Haves
- Prior Internship or rotational experience within the Pharmaceutical/Biotech industry a plus
- Exposure or familiarity with evaluating clinical trials, scientific literature and data
- Highly motivated and seek to build a career with a foundation in Clinical Sciences, Global Clinical Operations, Regulatory Affairs, and/or Safety Sciences
Responsibilities
- Drafting documents integral to clinical sites and regulatory submissions
- Analyzing data from clinical studies in preparation for interactions with ethics committees, senior management, regulatory authorities, and others
- Managing third-party vendors and maintaining timelines of key results
- Developing regulatory strategies for clinical development programs
- Analyzing safety data to characterize the safety profile of products throughout their development lifecycle
- Working with program mentors to improve skills to reach professional goals better
- Opportunities to travel to clinical sites and/or meetings with health authorities
Benefits
- 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
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
