ANJAN DRUG PVT. LTD is 25 years Old Bulk Drug Manufacturing company having 3 production facility around Chennai. More than 250 employees. USFDA/EDQM Approved, Supplier to almost all major Pharma companies throughout the world. Poised for Rapid Growth to become 200CR+ company.
Anjan Drug Job vacancy
Job Summary:
- Designation : Executive/ Sr.Executive
- Qualification : B.Pharm / M.Pharm / M. Sc
- Department : Regulatory Affair
- No.of Openings:01
Job description
1. Responsible to prepare drug master files and submission of same to agencies and co-ordinate with regulatory consultant for regulatory submissions.
2. Responsible for DMF life cycle management in various markets such as US, EU, Health Canada, ANVISA and other ROW markets . (If any one or two markets experience also would be fine)
3. Responsible to co-ordination with regulatory agencies for submissions and deficiency clarifications.
4. Responsible to resolve deficiencies and queries from customer and regulatory agencies.
5. DMF data Management.
6. Responsible to prepare tech packs.
7. Responsible to submit applicant parts or sponsor parts to the customers or Regulatory Agencies as per requirement
8. Responsible to provide essential regulatory guidance in the drug development stages.
9. Keep on update with regulatory requirements.
10. Regulatory risk assessment in change controls.
11. Responsible to submit application for new, renewals and maintaining the drug licenses with the drug control authorities (Both Central and State)
Responsible to submit application or obtain approval of any regulatory related notifications to the drug control authorities (Both Central and State)
Interested candidates share resume to mathi.mathiyazhagan@sekhmetpharma.com
Also Read: Aurobindo Pharma – Walk-Ins for Multiple Positions in Production / QC / QA / Packing / Manufacturing / Warehouse on 9th July’ 2023..
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