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Regulatory Affairs Specialist

5.0 - 10.0 years

6 - 16 Lacs

Gurugram

Posted:2 weeks ago| Platform: Naukri logo

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Skills Required

Regulatory Affairs US Market Drug Regulatory Affairs Dossier Preparation Dossier LCM

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 Note:- We are specifically looking for professionals with prior experience in US/EU Market.

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Sun Pharma
Sun Pharma
www.sunpharma.com

Pharmaceuticals

Mumbai

40,000+ Employees

187 Jobs

    Key People

  • Dilip Shanghvi

    Managing Director

  • Kedar T. Kachole

    Executive Vice President - Corporate Affairs

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