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Job Posting: Manager, Regulatory Affairs CMC at MSD
Requisition ID: R259256
Type: Full time
At MSD, we are a research-driven biopharmaceutical company dedicated to following the science to develop medicines and vaccines that make a significant impact on the world. Our mission is to provide innovative healthcare solutions to patients across the globe. Our Regulatory Affairs team plays a crucial role in facilitating communications and procedures that ensure compliance with regulatory agencies, enabling us to bring new medical advancements to the world. Join us to make meaningful contributions to global medical advancement.
Job Description
The Manager, Regulatory Affairs CMC will be responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance, and defined regulatory strategies. They will also prepare and review information required for the development of regulatory CMC dossiers for commercial products.
Key Responsibilities
Regulatory Responsibilities:
- Provide input to global product and project regulatory strategies, assessing CMC changes, global regulatory requirements, and evaluating supporting documentation.
- Lead the development, authoring, and review of CMC submission components and documentation to support post-approval supplements, variations, annual reports, registration renewals, and responses to health authority questions.
- Liaise with global CMC, our Manufacturing Division, and external partners to ensure compliance with change management and regulatory conformance.
- Identify and communicate potential regulatory risks and propose mitigation strategies.
- Deliver all regulatory milestones for assigned products across the product lifecycle.
- Report potential regulatory issues to GRACS CMC management when necessary.
Technical Skills:
- Review scientific information to assess technical merits and suitability of scientific rationale.
- Demonstrate strong oral and written communication skills to present issues clearly and logically.
- Understand related fields such as pharmaceutical manufacturing, analytical testing, and quality assurance.
- Proficient in computer skills and electronic document-based GMP systems.
Leadership Skills:
- Generate innovative solutions to problems and effectively communicate with key stakeholders.
- Adapt to changing priorities and unexpected events.
- Manage multiple priorities and balance work to achieve business goals.
- Demonstrate effective leadership, communication, and interpersonal skills.
Qualifications & Skills
- Bachelor’s degree in science, engineering, or a related field (advanced degree preferred).
- 5-7 years of industry experience in the pharmaceutical industry, with at least 4 years managing CMC Regulatory submissions for small molecules, vaccines, or biologics.
- Willingness to travel to other CMO sites as needed.
To apply for this position, please visit the link.
Keywords: Manager Regulatory Affairs CMC, Pharmaceutical industry, CMC Regulatory strategies, Global regulations, Scientific information, Regulatory dossiers, Compliance, Leadership skills, Pharmaceutical manufacturing
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