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Senior Executive Regulatory Affairs

Senior Executive Regulatory Affairs

Lifecell

2 - 5 years

3 - 5 Lacs

Jhajjar

Posted:1 day ago| Platform:

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Skills Required

Regulatory Affairs CMC USFDA

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Work from Office

Job Type

Full Time

Job Description

Key Responsibilities: Preparing and submission of Sterile Finished Product application CT-10, CT-12, CT-16, CT-21, Form-30, Free sale certificate, Certificate of Pharmaceutical Product, WHO-GMP. Endorsement of Sterile product under the manufacturing licence. Licensing to State drug controller & for getting the licence within a time period given by management. Submission of IND & NDA application of biological products (Cell lines/Tissue Engineered products) Compilation & review of Dossier according to CTD Modules (Module -1,2,3,4 and 5). Review the CMC documents of new product development. Compilation and review of Medical device(s)- Device Master Files. Preparation of the dossier as per checklist of CDSCO MD Rules 2017. Submission of WholeSale & Retails Licence. Labelling and Implementation of Medical Devices, Drug product, Biological product & Cosmetics products. Requirements: Education: Bachelors/Masters degree in Pharmacy, Life Sciences, or a related field. Experience: 3-5 years in Regulatory Affairs within the pharmaceutical, biologics, or medical device industry. Skills: Knowledge of CDSCO, WHO-GMP, and CTD guidelines, experience in dossier preparation & regulatory submissions, strong coordination skills, and understanding of Medical Device Rules 2017. Important Note: "For the first 6 months, the training will be at the Head Office located in Chennai. Travel expenses and accommodation will be provided by the company." Contact us; Siva - 7826802077 Email Id - azaruddin.a@lifecell.in sivaprasad.m@lifecell.in

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Lifecell

acelity.com/

Biotechnology Research

San Antonio TX

5001-10000 Employees

43 Jobs

Key People

Danielle C. Rader

Chief Executive Officer
David A. Kessler

Chief Financial Officer
Michael S. McGuire

Chief Operating Officer

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Senior Executive Regulatory Affairs

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