Officer / Senior Officer - Regulatory Affairs (API)

1 week ago

Mumbai, Maharashtra, India Kopran Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities

  1. Preparation of DMFs for regulated (US, EU) & ROW markets.

  2. Preparation of lifecycle management submissions (amendments / revisions) for the filed DMFs.

  3. Preparation of response to deficiencies from regulatory authorities & customers.

  4. Coordination with cross functional teams for data / documents.

Preferred candidate profile

  1. Candidate should be M.Sc. Chemistry with 3-4 years' experience in a reputed pharma industry, preferably in API RA.

  2. Should possess good knowledge of ICH guidelines and regional regulatory requirements for US, EU, Brazil & other ROW markets.

  3. Should have handled DMF & deficiency response submissions.

Should have strong analytical & interpersonal communication skills.

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