PharmD Program Associate - Regulatory Labeling & Advertising/Promotion

About the role

The PharmD Program is an intensive, interdisciplinary program designed for graduating PharmD and/or PhD candidates. It includes training by Regeneron mentors and hands-on experience in various global development roles within the company.

Responsibilities

• Acquire technical and non-technical skills through diverse training, cross-functional experiences, and mentorship.
• Exposure to critical issues and decision-making processes in clinical operations, program management, clinical sciences, regulatory strategy, and safety sciences.
• Develop regulatory strategies for clinical development programs and analyze safety data.
• Manage third-party vendors and maintain timelines of key results.
• Contribute to the development of labeling content and strategies, and support the labeling process throughout the product lifecycle.
• Support FDA-Office of Prescription Drug Promotion (OPDP) interactions and ensure promotional communications are truthful and not misleading.
• Draft documents integral to clinical sites and regulatory submissions, analyze data from clinical studies, and manage interactions with ethics committees, senior management, and regulatory authorities.
• Develop knowledge and skills to interpret FDA regulations and guidances to advise teams on associated regulatory risks.
• Gain exposure to different functional areas through an optional elective rotation.

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.
• 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 seeking 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.

Qualifications

• Strong academic background in pharmacy or a related life science field.
• Excellent communication and problem-solving skills.
• Ability to work independently and collaboratively.
• Passion for advancing healthcare through innovative research and development.

Skills

• Technical skills in clinical operations, program management, clinical sciences, regulatory affairs, and safety sciences.
• Strong analytical and data-driven skills.
• Effective written and verbal communication skills.
• Ability to work in a fast-paced, dynamic environment.

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 (medical, dental, vision, life, and disability).
• Paid time off.
• Family support benefits.

Pay

$98,100.00 - $160,100.00 annually

Schedule

Full-time, 40 hours per week