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Alembic Pharmaceuticals
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Executive or Senior Executive - Regulatory Affairs - Europe & SA.

Executive or Senior Executive - Regulatory Affairs - Europe & SA.

Alembic Pharmaceuticals

4 - 7 years

5 - 9 Lacs

Vadodara

Posted:1 month ago| Platform:

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Skills Required

Regulatory Affairs Dossier Preparation Dossier RA

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Job Type

Full Time

Job Description

Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Executive / Sr. Executive based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 4 - 8 yrs. with dossier filling experience in Europe & South Africa Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skills. Job Description: Review of product initiation form /extension form Review of technology transfer documents Dossier compilation / periodic updates in dossier checklist CTD/NeeS/eCTD Submission & correspondence with agency / customer CoPP Dossier online review, submission with customer / agency & assessment phase Post approval life cycle management i.e. variation, renewal, updated dossier, variation status Interested candidate can share cv on creyesha.macwan@alembic.co.in

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Alembic Pharmaceuticals

www.alembicpharmaceuticals.com

Pharmaceuticals

Vadodara

Approximately 4,500 Employees

95 Jobs

Key People

Mr. Chirag Patel

Managing Director
Mr. Vasant V. Sanghvi

Chairman
Mr. Arun R. Suthar

Chief Financial Officer
Dr. Abhay S. Bhatt

President and Head of R&D

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Executive or Senior Executive - Regulatory Affairs - Europe & SA.

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Executive or Senior Executive - Regulatory Affairs - Europe & SA.

Experience & Salary

Skills Required

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