Senior Officer-Regulatory Affairs

Provide regulatory support to customers/ internal teams and assist in maintaining regulatory requirements at all levels

Coordinate 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 officials

Coordinate with Global Regulatory Affairs (GRA) for support required regarding new regulations/ advisories, regulatory queries/ assessments/ documents, raw material information

Provide assistance to RA associates locally and at GRA

Work on local/ global projects assigned from time to time and meet deadlines

Assist 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 issues

Track changes on regulations for Excipients and colors and provide update

Attend Global Regulatory Trainings and meetings – locally and overseas