ZCL Chemicals Ltd Job Vacancy For Regulatory Affairs Department

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●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.

●Work Profile:-

◆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.

Interested candidates can drop their updated CV to:- Hiring@zclchemicals.com

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