Principal Scientist – Regulatory Affairs, CMC
MSD
full-time
Posted on:
Location Type: Hybrid
Location: North Wales • Massachusetts • New Jersey • United States
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Salary
💰 $190,800 - $300,300 per year
Job Level
About the role
- Responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies
- Leading the preparation and submission of CMC sections for commercial or new biologics products
- Provide CMC Regulatory leadership within Regulatory and on cross-functional teams
- Develop and execute detailed global regulatory submissions
- Collaborate with partner groups to ensure compliance, scientific excellence, accuracy, and completeness of submissions
- Resolve complex project issues through collaboration and provide recommendations to Regulatory CMC leadership team as appropriate.
Requirements
- B.S. in a biological science, engineering, or a related field (advanced degree preferred)
- At least ten years of relevant experience including biologics or vaccine Regulatory CMC, or development; manufacturing, testing, or licensure of biological products; or closely related fields.
- Strong listening skills.
- The candidate must be proficient in English; additional language skills are a plus.
- The candidate may be required to travel on a periodic basis.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategiesglobal regulatory submissionsbiologicsvaccine developmentmanufacturingtestinglicensure of biological products
Soft Skills
leadershipcollaborationproblem-solvinglistening skillscommunication