PharmD Program Associate - Regulatory Labeling & Advertising/Promotion
Regeneron
August 24, 2026
On-site
Tarrytown, NY
Marketing
Program (24-month rotational experience) responsibilities:
- Draft documents integral to clinical sites and regulatory submissions.
- Analyze data from clinical studies to prepare for interactions with ethics committees, senior management, regulatory authorities, and others.
- Manage third-party vendors and maintain timelines of key results.
- Develop regulatory strategies for clinical development programs.
- Analyze safety data to characterize the safety profile of products throughout their development lifecycle.
- Work with program mentors to improve skills toward professional goals.
- Support labeling and labeling strategies by interpreting regulations and guidelines; support labeling process across the product lifecycle (e.g., Labeling Working Group reviews and management approvals).
- Interpret FDA regulations and guidances to ensure promotional communications are truthful and not misleading; advise teams on regulatory risks; support FDA-OPDP interactions.
- Opportunities to travel to clinical sites and/or meetings with health authorities.
This role requires:
- Post-doctoral graduates from an accredited (ACPE) College of Pharmacy (PharmD); PhD graduates in a life science-related area may also be considered.
- PharmD and/or PhD completed by Summer 2027.
- Prior internship or rotational experience in the Pharmaceutical/Biotech industry (plus).
- Exposure or familiarity evaluating clinical trials, scientific literature, and data.
- Highly motivated; building a career foundation in Clinical Sciences, Global Clinical Operations, Regulatory Affairs, and/or Safety Sciences.
- Eligible to work in the U.S. on a permanent basis.
Application instructions:
- Include a resume and cover letter specifying the track of interest; if applying to more than one track, rank them in order of preference.
- Applications accepted: August 24, 2026 – September 11, 2026.
- Draft documents integral to clinical sites and regulatory submissions.
- Analyze data from clinical studies to prepare for interactions with ethics committees, senior management, regulatory authorities, and others.
- Manage third-party vendors and maintain timelines of key results.
- Develop regulatory strategies for clinical development programs.
- Analyze safety data to characterize the safety profile of products throughout their development lifecycle.
- Work with program mentors to improve skills toward professional goals.
- Support labeling and labeling strategies by interpreting regulations and guidelines; support labeling process across the product lifecycle (e.g., Labeling Working Group reviews and management approvals).
- Interpret FDA regulations and guidances to ensure promotional communications are truthful and not misleading; advise teams on regulatory risks; support FDA-OPDP interactions.
- Opportunities to travel to clinical sites and/or meetings with health authorities.
This role requires:
- Post-doctoral graduates from an accredited (ACPE) College of Pharmacy (PharmD); PhD graduates in a life science-related area may also be considered.
- PharmD and/or PhD completed by Summer 2027.
- Prior internship or rotational experience in the Pharmaceutical/Biotech industry (plus).
- Exposure or familiarity evaluating clinical trials, scientific literature, and data.
- Highly motivated; building a career foundation in Clinical Sciences, Global Clinical Operations, Regulatory Affairs, and/or Safety Sciences.
- Eligible to work in the U.S. on a permanent basis.
Application instructions:
- Include a resume and cover letter specifying the track of interest; if applying to more than one track, rank them in order of preference.
- Applications accepted: August 24, 2026 – September 11, 2026.