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Executive / Asst. Manager - Regulatory Affairs (API)

Executive / Asst. Manager - Regulatory Affairs (API)

Kopran

6 - 8 years

6 - 10 Lacs

Mumbai Mumbai Suburban Mumbai (All Areas)

Posted:1 month ago| Platform:

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Skills Required

Row Market API Europe Market Dmf US Market R&D

Work Mode

Work from Office

Job Type

Full Time

Job Description

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. Review of the data for DMF preparation received from mfg. site and R&D and ensuring required corrections. 5. Coordination with cross functional teams for data / documents. Review of the DMFs & other submissions prepared by the team. Preferred candidate profile 1. Candidate should be M.Sc. Chemistry with 6-8 years experience OR B.Sc. - Chemistry with 8 years plus relevant work 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 individually handled DMF & deficiency response submissions. Should have strong analytical & interpersonal communication skills.

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Kopran

Pharmaceutical Manufacturing

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Executive / Asst. Manager - Regulatory Affairs (API)