Rhydburg
JB-204 – Executive, Regulatory Operations
Company
Role
JB-204 – Executive, Regulatory Operations
Location
Job type
Full-time
Found on Mokaru
4 months ago
Salary
Job description
Job Description Support regulatory submissions and routine regulatory operations execution activities. Assist senior team members with document uploads and portal navigation tasks. Maintain regulatory trackers, logs, and structured follow-up documentation. Coordinate routine follow-ups with agents and internal departments regularly. Prepare, compile, and track PP, FSC, and COPP applications accurately. Coordinate with State Licensing Authorities and CDSCO for PP, FSC, and COPP. Track acknowledgements, clarifications, and approvals issued by authorities. Archive submission proofs, approvals, receipts, and certificates systematically. Assist in preparation of regulatory MIS reports and status summaries. Support daily regulatory operations under defined supervision and guidance. Requirements Requirements Bachelor’s degree in Pharmacy Science or related discipline is mandatory. Zero to two years experience in regulatory affairs or regulatory operations roles. Basic understanding of State FDA and CDSCO regulatory processes. Familiarity with PP, FSC, and COPP documentation requirements preferred. Strong documentation, follow-up, and coordination discipline required. Benefits Benefits Option to work from home or office based on role requirements. Flexible working schedule with guided supervision structure. Exposure to Indian licensing authorities and global certification workflows.


