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Merck Sharp & Dohme (MSD)
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Manager, Regulatory Affairs CMC

Manager, Regulatory Affairs CMC

Merck Sharp & Dohme (MSD)

9 - 15 years

30 - 40 Lacs

hyderabad pune

Posted:-1 days ago| Platform:

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Skills Required

cvs manager quality assurance policy implementation analytical pharma cmc regulatory compliance manager regulatory affairs nda regulatory affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsible for implementing CMC regulatory strategies for assigned products in
accordance with global regulations and guidances; and is responsible for the preparation and submission of CMC dossiers for pipeline and commercial products. Accountable for the delivery of regulatory milestones for less complex projects through the product lifecycle. Participate in the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for smaller-scoped projects. Execution of CMC documentation including IND/CTA, NDA/BLA/MAA, post approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Experience in reviewing scientific information and assessing whether technical arguments are clearly presented, and conclusions are adequately supported by data. Applying oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills. Applying understanding of related fields (e.g., manufacturing, analytical, quality assurance). Flexibility in responding to changing priorities or dealing with unexpected events

Required Skills:

Adaptability, Communication, Compliance Investigations, Documentation Standards, Electronic Common Technical Document (eCTD), Employee Training Programs, Global Regulatory Submissions, Management Process, Pharmaceutical Manufacturing, Policy Implementation, Records Retention Management, Regulatory Affairs Compliance, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Strategy Development, Regulatory Submissions, Stakeholder Communications

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Merck Sharp & Dohme (MSD)

Pharmaceuticals

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Manager, Regulatory Affairs CMC