PharmD Program Associate - Regulatory Strategy
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. The regulatory associate will support global regulatory planning and execution to support the clinical development, approval, and lifecycle management of pharmaceutical products. This position partners cross-functionality to define innovative regulatory pathways, ensure compliance with global health authority requirements and guidances, and produce and manage timelines and deliverables across multiple programs. The associate will provide strategic input on operations and submissions to global regulatory authorities to enable efficient and successful product development.
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.
- You must have completed your PharmD and/or PhD degree by Summer 2027
- You are 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
- You are 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Ph.D. or professional degree
