Interview Data Loading …We ZCL Chemicals LTD (A subsidiary of Advent International), An API Manufacturers based GIDC, Ankleshwar is hiring for below:
Senior Officer/Executive - Regulatory Affairs (API Exposure)
Qualifications: M.Sc. (Organic Chemistry)/M. Pharma (RA)
Experience Required: 3 to 6 years of Experience in core RA in API Pharma manufacturing is preferable.[ads id="ads1"] 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[ads id="ads2"] requirement.
⚫ cGMP and GLP related compliance.
-Well versed with Pharma Reddy Software.
Interested candidates can drop their updated CV to
[ads id="ads1"]
Interview Data Loading …
We ZCL Chemicals LTD (A subsidiary of Advent International), An API Manufacturers based GIDC, Ankleshwar is hiring for below:
Senior Officer/Executive - Regulatory Affairs (API Exposure)
Qualifications: M.Sc. (Organic Chemistry)/M. Pharma (RA)
Experience Required: 3 to 6 years of Experience in core RA in API Pharma manufacturing is preferable.
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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
[ads id="ads2"]
requirement.
⚫ cGMP and GLP related compliance.
-Well versed with Pharma Reddy Software.
Interested candidates can drop their updated CV to
[ads id="ads1"]