Ind-swift Laboratories Derabassi Vacancy | Regulatory Affairs Vacancies

Attention all pharmaceutical professionals! We are currently hiring Officer/Executive in Regulatory Affairs department at Ind Swift Limited (GBU) 100% EOU (OSD Formulation Site), Derabassi, Distt-Mohali.

Qualification: – B.Pharma/M.Pharma Experience: – 04 to 08 years Location: – Panchkula & Gurugram

Preparation and review of registration dossiers as per CTD/ACTD and country specific formats for RoW & Europe & US Market. 2. Compilation of response to queries received from regulatory authorities/clients.

3. Compilation of Variation and Re-registration documents as per required checklist. 4. Review of quality documents like API’s DMF, Finished Product Specification, Certificate of Analysis, BMR, BPR, Process Validation and Stability etc. for guidelines Compliance.

3. Compilation of Variation and Re-registration documents as per required checklist. 4. Review of quality documents like API’s DMF, Finished Product Specification, Certificate of Analysis, BMR, BPR, Process Validation and Stability etc. for guidelines Compliance.

5. Coordination with various departments like QA, QC and Production, to project the document requirements for appropriate submissions.

6. Compilation of documents to bid international tenders for ROW markets. 7. Preparation and review of SPC, Product monograph, package insert and labeling information.

If you are interested in joining our team, please send your CV at hr.gbu@indswiftlabs.com. We look forward to reviewing your application and potentially welcoming you to our team.