Principal Scientist (director) - Regulatory Affairs-cmc

Merck Sharp & Dohme Corp

Base: $190,800.00 - $300,300.00; bonus/equity: eli...
**
Cmc regulatory strategies for biologics
Preparation and submission of cmc sections
Global cmc guidelines
** Merck Sharp & Dohme Corp is seeking a Principal Scientist/Director for Regulatory Affairs in Chemistry, Manufacturing, and Controls (CMC) for biologics products. The position involves developing regulatory strategies, leading submissions, and mentoring junior scientists within a hybrid work environment. **

Job Summary

  • The Principal Scientist / Director is responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biologics product franchises.
  • Responsibilities include serving as a Regulatory CMC Project Lead, providing CMC Regulatory leadership, and leading the preparation and submission of CMC sections for commercial or new biologics products.
  • The role requires demonstrated understanding of regulatory affairs to ensure the approval or continued market supply of biologics products worldwide, with an unwavering focus on compliance.

Matching Summary

Match Score: 75

** Merck Sharp & Dohme Corp is seeking a Principal Scientist/Director for Regulatory Affairs in Chemistry, Manufacturing, and Controls (CMC) for biologics products. The position involves developing regulatory strategies, leading submissions, and mentoring junior scientists within a hybrid work environment. **

Salary

Base: $190,800.00 - $300,300.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, retirement, paid holidays, vacation, sick days

Skills & Requirements

Must-have

  • CMC regulatory strategies for biologics
  • preparation and submission of CMC sections
  • global CMC guidelines
  • IND/BLAs or post approval changes
  • regulatory CMC project lead
  • scientific excellence and accuracy

Nice-to-have

  • creative and imaginative problem solving
  • flexibility in responding to changing priorities
  • effective communication with stakeholders
  • cross-cultural awareness

Key Requirements

  • At least ten years of relevant experience
  • BS in biological science, engineering, or related field
  • Proficient in English
  • Regulatory CMC experience in biologics or vaccine
  • Experience with IND/BLAs or post approval changes

Work Rights

Not specified

Tailored Resume

Cover Letter