Senior Officer-Regulatory Affairs

2 weeks ago


new delhi, India COLORCON ASIA PRIVATE LIMITED Full time

Provide regulatory support to customers/ internal teams and assist in maintaining regulatory requirements at all levelsCoordinate for acquiring / renewal of FDA/FSSAI licenses, product approvals, chemist intimations/ approvals, maintain regulatory documentation and follow up on any Corrective action directed by the FDA officialsCoordinate with Global Regulatory Affairs (GRA) for support required regarding new regulations/ advisories, regulatory queries/ assessments/ documents, raw material informationProvide assistance to RA associates locally and at GRAWork on local/ global projects assigned from time to time and meet deadlinesAssist in implementation of Regulatory strategy in line with Global and Local strategies as required.Maintain Customer support system metrics, suggest improvements and coordinate with IT to resolve system issuesTrack changes on regulations for Excipients and colors and provide updateAttend Global Regulatory Trainings and meetings – locally and overseas



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