ZCL Chemicals Ltd Job Opening For Regulatory Affairs |
- Post Name: REGULATORY AFFAIRS
- Qualification:Any Graduate,Any Postgraduate in Any Specialization
- Experience:04-9 years
- Location:Ankleshwar
- Address:PLOT NO 3102/B,,ZCL CHEMICALS LTD,GIDC,ANKLESHWAR, , , BHARUCH, Gujarat, India
- Salary: NA
- Openings:NA
Job Description: Hiring For REGULATORY AFFAIRS in ZCL Chemicals Ltd!
Roles and Responsibilities
- To support Life cycle management requirements at plant level in coordination with CRA API / Quality assurance and manufacturing.
- To Support DMF filing and Deficiency responses and provide appropriately reviewed data generated at plant level.
- To review change controls and propose Category of submission at various markets. To review specifications & test methods of raw materials, packaging materials and API for routine revisions.
- To check regulatory adequacy of API batches manufactured at manufacturing site to support regulatory filings.
- To provide regulatory support to API manufacturing sites during Customer & Regulatory Audits.
Desired Candidate Profile
To update API manufacturing sites about approval of various regulatory submissions and to ensure implementation of proposed changes involved in corresponding submission.
Perks and Benefits
Best in the Industry
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