Officer / Senior Officer - Regulatory Affairs (API)

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.

4. Should have strong analytical & interpersonal communication skills.