Regulatory Compliance Specialist

2 weeks ago


Gurgaon, Haryana, India Coral Drugs. Pvt. Ltd. Full time

Coral Drugs. Pvt. Ltd. is seeking a Regulatory Compliance Specialist to lead the preparation and compilation of DMF for various semi-regulated markets.

Key responsibilities include the submission of technical data packages and applicant parts for semi-regulated markets, as well as the submission of responses to deficiencies received from authorities and customers.

The ideal candidate will have expertise in the use of eCTD software and submission gateways like ESG & CESP.

They will also be well-versed in current regulatory guidelines and trends, and able to identify gaps in regulatory submissions.

Other responsibilities include the maintenance of a database for regulatory submissions, including customer notifications.

The successful candidate will be able to work effectively in a team environment and communicate complex regulatory information to both technical and non-technical stakeholders.



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