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Encube hiring Regulatory affairs Candidates

Designation – Assistant Manager/Manager

Department : Regulatory Affairs

Educational Qualification : M.Pharm

Work Experience : 6-8 years

Location : Andheri (East)

Key Deliverables

1. Defining EU/UK regulatory strategy.

2. Dossier review and complilation of MA application for EU/UK market.

3. In-depth knowledge of documents such as specification, batch record, method validation documents, stability data, container, closure system, DMF review.

4. Hands on experience in compiling eCTD.

5. Labeling related activites 6. Post Approval activities for EU/UK.

Skills Requirments

1. Team handling experience of 1-2 team members.

2. Preferred advantage if other
regulated market exposure e.g ROW market.

3. Thorough Knowlege on the review of CMC/clinical documentation required for submission.

4. Preferred advantage for having an exposure in topical products.

5. Good communication skills and interpersonal skills.

6. Ability to co-ordinate to project manage with external stakeholder.

Interested Candidates share your updated Resume to
durga.p@encubeethicals.com careers@encubeethicals.com

See also  Zydus Healthcare; Multiple pharma job openings; QC, QA, Production, engineering Departments
Regulatory affairs Experience Jobs in Andheri; Encube

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