●Department:-Regulatory Affairs (API Exposure)
●Designation:- Senior Officer / Executive
●Qualifications: M.Sc. (Organic Chemistry) / M. Pharma (RA)
●Experience:- 3 to 6 years of Experience in core RA in API Pharma manufacturing is preferable.
◆Technology Transfer document review for adequacy with respect to the regulatory requirements.
◆Compilation & review of Drug Master File for regulatory filings. Regulatory communication with marketing department.
◆Filing of annual reports and amendment.
◆Preparation of response for DMF deficiencies received from agency as well customers.
◆Evaluation of change with respect to regulatory impact and informed to customer through marketing.
◆Coordination with other departments for regulatory requirements including deficiency response.
◆To ensure to meet scheduled date for DMF filing as per planner discussed and agreed upon.
◆Coordination with another department for customer questionnaire requirement.
◆CGMP and GLP related compliance.
◆Well versed with Pharma Reddy Software.
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