Officer / Senior Officer - Regulatory Affairs (API)
2 weeks ago
Role & responsibilities
Preparation of DMFs for regulated (US, EU) & ROW markets.
Preparation of lifecycle management submissions (amendments / revisions) for the filed DMFs.
Preparation of response to deficiencies from regulatory authorities & customers.
Coordination with cross functional teams for data / documents.
Preferred candidate profile
Candidate should be M.Sc. Chemistry with 3-4 years' experience in a reputed pharma industry, preferably in API RA.
Should possess good knowledge of ICH guidelines and regional regulatory requirements for US, EU, Brazil & other ROW markets.
Should have handled DMF & deficiency response submissions.
Should have strong analytical & interpersonal communication skills.
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