Regulatory Affairs Manager- API

Role & responsibilities -

Designation - Regulatory Affairs - Assistant Manager to Manager - API

Experience - 8 to 15 Years

1. Responsible for submissions and Lifecycle Management - Europe/UK/US/Canada/WHO

and ROW market.

2. Preparing Nitrosamine Risk Assessment Report for Spartans and other drug substances.

3. Submissions of USDMF, EU-ASMF, CEP, WHO and Health Canada query responses to

the respective regulatory authorities through electronic submissions. (ESG, CESP

submissions).

4. Submission of US-Amendments/ASMF Updates/CEP Revisions adequately based on

changes proposed for the drug Substances.

5. Notifications of US-Amendment/ASMF Update/CEP Revision to relevant customers.

6. Preparing and compiling DMF/Technical Packages & Dossiers for submission to the

Regulatory Agencies of the various countries (US, Europe, WHO, Canada & ROW).

7. Knowledge and experience in preparation & reviewing of Module 1 to Module 3 CMC

Documentation. Compiling eCTD sequences through Pharma ready.

8. Review of Validation reports, Stability studies, Specifications/ Method of Analysis, Batch

Manufacturing Records (BMRs/MFRs), Pharmaceutical Development Reports (PDR).

9. Interact with various departments/teams for regulatory documents and compilation on time

as per regulatory requirements.

10. Maintenance of the complete history of each drug substance (Filing history with

agencies/customers, deficiency responses, amendments, annual reports).

11. Issue Letter of Access and other relevant regulatory documents and their submission to

regulatory authorities.

12. Review of all documents from QA, R&D, AR&D, Production and other department with

respect to correctness and compliance for regulatory submission.

13. Audit Faced: WHO-GENEVA, USFDA, EDQM and Customer audits.

Preferred candidate profile

Perks and benefits