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11/12 Yo Hr Consultancy
HR Manager at Yo HR Consultancy

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Officer - Regulatory Affairs (2-5 yrs)

Delhi Job Code: 38919

Regulatory Affairs Officer

Location : Delhi (Office Only)

Experience : 2-5 Years

Must-Have :

- USFDA Regulation 510(K) Compliance as per 21CFR 821.

- Co-ordinate with QC, QA, R&D, MSAT, Regulatory affairs teams on day-to-day activities.

Job Responsibility :

- Responsible for product submissions, license renewals, periodic updates and registrations to regulatory agencies.

- Review product changes for impact on regulatory filings, and research regulatory issues and provide guidance and advice to colleagues.

- Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy.

- Maintain regulatory files/database and chronologies in good order.

- Establish and maintain system for tracking changes in documents submitted to agencies or partners

- Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products

- Well versed with cGMP, GDP, GLP, ICH Guidelines.

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