RA Manager / Sr. Manager

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.