Specialist - Regulatory Affairs (Pharmaceuticals)

Keen learner for guidelines relating to HA, local laws / authorities, for Drugs, Medical Devices, Cosmetics and Food/ Health Supplements

Closely follow the team leader and understand the guidelines, practices, and standards to be followed for various submissions and activities. 

Compilation and submissions to HA, both offline / online, and following up for status of dossiers / queries.

Responding to necessary queries, and meeting with HA for resolution of queries, and follow up for status of applications.

Represent clients for all matters relating registrations and audits and communicate with clients within the country for resolving queries / FDA issues.

Ensure upkeep and safe custody of all original documents and records

Stay updated and continuously update internal documentation with reference to guidelines

Team management and ensuring effective communication with the HA. 

Monitor, supervise project deliverables. Ensure that SOPs are complied with and updated. 

Monitoring project status and periodically verifying their status with FDA in person and online portal