Regulatory Affairs Manager at MSD – Apply Online
MSD, a global leader in pharmaceutical innovation, is seeking a Manager, Regulatory Affairs – CMC, to drive compliance and regulatory strategies for pharmaceutical products. This role involves leading CMC submissions, risk assessment, and regulatory milestone delivery while collaborating with global teams.
If you have expertise in pharmaceutical manufacturing, regulatory compliance, and CMC submissions, this is your chance to contribute to groundbreaking medical advancements. Apply now to be part of MSD’s mission to bring innovative healthcare solutions to the world!
About MSD
MSD is a global pharmaceutical company focused on bringing new medical advancements to the world by facilitating communications and procedures that ensure compliance with regulatory agencies. Our international network is committed to healthcare breakthroughs, providing innovative and compliant medical products, practices, and solutions worldwide.
Job Title: Manager, Regulatory Affairs – CMC
Job Description:
This role is crucial to implementing CMC regulatory strategies for pharmaceutical products in compliance with global regulations and defined strategies. Responsibilities include preparing and reviewing information for regulatory CMC dossiers of commercial products.
Primary Responsibilities:
- Provide input to global product regulatory strategies
- Lead the development and review of CMC submission components
- Liaise with global CMC and external partners
- Assess and propose mitigation strategies for regulatory risks
- Deliver regulatory milestones across product lifecycle
Technical Skills:
- Experience in assessing scientific information
- Demonstrated oral and written communication skills
- Understanding of pharmaceutical manufacturing and quality assurance
- Proficient in electronic document-based GMP systems
Leadership Skills:
- Generate innovative solutions
- Handle multiple priorities effectively
- Demonstrate effective leadership and communication skills
Qualifications & Skills:
- Bachelor’s in Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry
- Minimum 5 – 7 yrs of Industry Pharmaceutical industry experience out of 4 years’ experience in managing CMC Regulatory submissions for small molecules/vaccines/biologics The candidate may be required to travel to other CMO sites on a need basis.
Employee Status: Regular
Relocation: Not specified
VISA Sponsorship: Not specified
Travel Requirements: Travel required
Flexible Work Arrangements: Hybrid
Shift: Not specified
Valid Driving License: Required
Hazardous Material(s): No
Job Posting End Date: 03/31/2025
and join our dynamic team at MSD.
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