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USV Limited
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Manager RA (CMC)

Manager RA (CMC)

5 - 14 years

|

10 - 14 Lacs

Posted:3 hours ago| Platform:

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Skills Required

pharmaceutical ich-gcp guidelines anda regulatory gmp dcgi ich qc ctd qms regulatory affairs drug regulatory affairs solid orals ectd fda usfda documentation dossier ent nda emea ra quality assurance cmc dmf actd who

Work Mode

Work from Office

Job Type

Full Time

Job Description

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 ( RD, 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.

More Jobs at USV Limited

Manager RA (CMC)

mumbai

INR 10 - 14 Lacs

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