About the Role
The PharmD Program is an intensive, interdisciplinary program for graduating PharmD and/or PhD candidates, offering training by Regeneron mentors and experience leading projects in global development roles. This 2-year program provides participants depth and breadth of experience within Regeneron's Global Development organization, acquiring technical and non-technical skills through diverse training, cross-functional experiences, and ongoing mentorship.
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
- Contribute to the development of labeling content and labeling strategies through interpretation of regulations and guidelines
- Support the labeling process throughout the product lifecycle, including Labeling Working Group reviews and management approvals
- Develop knowledge and skills to interpret FDA regulations and guidances to ensure promotional communications are truthful and not misleading
- Advise teams on associated regulatory risks
- Support 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
- Prior Internship or rotational experience within the Pharmaceutical/Biotech industry is 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
- Eligible to work in the U.S. on a permanent basis
- Resume and cover letter specifying the track of interest required upon application
- Rank tracks in order of preference if interested in more than one
Skills
- Clinical Sciences
- Global Clinical Operations
- Regulatory Affairs
- Safety Sciences
Location
- Tarrytown, NY
Work Type
- On-site
Experience Level
- Post-doctoral
- Rotational experience
Education Level
- PharmD
- PhD
Salary/Compensations
- $98,100.00 - $160,100.00
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
About the Company
- Regeneron is committed to building a workplace with an inclusive culture.
- Regeneron offers a competitive and comprehensive total rewards package.
- We believe we do our best work when we are together.
Equal Opportunity
- 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.
