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Regulatory Affairs Executive/Sr. Executive

Regulatory Affairs Executive/Sr. Executive

Sun Pharma

4 - 9 years

5 - 14 Lacs

Gurugram

Posted:1 month ago| Platform:

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Skills Required

Regulatory Affairs Dossier US Market Canada Dossier Preparation CMC Europe Market

Work Mode

Hybrid

Job Type

Full Time

Job Description

Role & responsibilities :- Job Summary : Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations : a. Prepare and review variation , Annual notification and labelling approval for US and OAM b. Review of change control and file variation as per country requirement 4. Regulatory compliance: a. eCTD compilation b. Ensure reposition of comprehensive product information into central repository C. Review regulatory filing impact of variations, change controls, etc

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Sun Pharma

www.sunpharma.com

Pharmaceuticals

Mumbai

40,000+ Employees

188 Jobs

Key People

Dilip Shanghvi

Managing Director
Kedar T. Kachole

Executive Vice President - Corporate Affairs
Sanjay Patil

Chief Financial Officer
Mandeep Singh

Chief Operating Officer

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Regulatory Affairs Executive/Sr. Executive

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