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Regulatory Affairs Specialist
Job Description Responsible for day-to-day Regulatory Affairs activities including document change request reviews and approvals, regulatory agency submissions such an annual reports, Letters of Authorization, and Drug Master File amendments, in addition to responses to product specific customer inquiries.  Duties include: Prepares global regulatory documentation and registration in support of customers, and company's strategic business objectives; including but not limited to Drug Master Files, Annual Reports, and Supplements.  Current Geographical areas of emphasis are North America, European Union, Pacific Rim, Central America and South Africa. Approves all Change Requests, Variations, etc. for compliance to filed DMF parameters.


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