Manager RA(CMC)

7 days ago


Maharashtra India Govandi USV Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Job Responsibilities:

1. Biosimilar Regulated market submissions - US / EU market submission. Preferred US FDA .Alternatively candidates having exp in Small molecules and injectables for US.2. Should Have dossier authoring for CMC for EU market.3. Should have authoring of pre approval dossiers and query responses for US and EU.

4. Biosimilar Product Development Strategy for CMC and Clinical trials

5. Review of all Dossier related Quality documents including coordination with Cross functional teams ( R&D, QC/QA and Manufacturing) .

6. Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions

7. MOH Query response.

8. Biosimilar Product Life cycle Management.

9. RA support for Plant related QMS activities.



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