HR Manager at Yo HR Consultancy
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Officer - Regulatory Affairs (2-5 yrs)
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.
