OFFICER REGULATORY AFFAIRS

Preparation of CTD(Common Technical Documents) and ACTD(Asian Common Technical Documents) Dossiers for CIS (Commonwealth Independent States) and ROW (Rest Of World)

Reviewing factory documents like Specifications, MOA (Mode Of Action), COA (Certificate Of Analysis), BMR (Batch Manufacturing Records), PVP (Polyvinylpyrrolidone), PVR (Pharmaco Vigilance Regulation), MFR (Master Formula Records), Stability Data etc.Reviewing DMF (Drug Master File)

Reviewing Artworks and Labels.

Co-ordinating with Factory for Documents.

Preparation of Normative Document of Registered productsin CIS markets.Preparation of Excel sheet of Regulatory status.

Response to Queries.

Filing of Documents / Dossier.

Preparation of DMF.

Co-ordinating with respective person for Tender Documents.

Filing of NDA (New Drug Application) & MAA (Marketing Authorisation Application).

Other Regulatory / Compliances related responsibilities.

Liaisoning with National & International Authorities for Regulatory related work.

Candidate Profile:

Presently working in similiar capacity i.e. as Export Executive/Manager with any leading Pharma Company.

Candidate must be a Graduate/D.Pharm/B.Pharm or MBA preferably in Regulatory Affairs.

2 - 5+ years Andheri (E),Mumbai Local Resident of Mumbai preferred Male / Female Candidate Only

Only those candidates who have worked in Pharma Industry in this profile.