Principal Scientist (Manager), Global Regulatory Affairs, CMC
$117,000–$201,250 year
On-siteRaritan, New Jersey, United States or Horsham, Pennsylvania, United States
Job Summary
Lead global CMC regulatory activities for large molecules in clinical and post-marketing phases, developing submission plans and executing dossier preparations for Health Authorities. Establish and execute global regulatory strategies for drug and delivery device products, including vaccines and cell therapies, while representing CMC Regulatory Affairs on cross-functional teams. Drive continuous improvement in compliance with EU and FDA regulations, manage lifecycle management issues, and serve as a Single Point of Contact for internal and external stakeholders. Communicate critical regulatory issues to management and maintain positive relationships with health authorities. Requires 8+ years of experience in biologics and large molecules, with an MS, PhD, or Pharm.D. preferred. Base pay ranges from $117,000 to $201,250.
Required Qualifications
- A BS/BA in biological, pharmaceutical, chemical or engineering sciences
- Minimum of 8+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent
- Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry
- Experience in biologics
- Experience in product development/LCM of the large molecules
- The ability to potentially travel up to 10% travel, domestic and/or international
Desired Qualifications
- An MS, Ph.D., or Pharm. D. degree
- Experience developing regulatory strategies
- An understanding of product development
- Knowledge of EU and FDA regulations
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