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Hiring companyCentrient
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Specialist, Regulatory Affairs FDF
Gurugram, Haryana, India Full-time Hybrid
About the role
RA-FDF Team at Centrient ensures global regulatory approval and lifecycle management of pharmaceutical products. The Specialist prepares and updates product dossiers, variation packages, and supports pharmacovigilance and CMC data evaluation. Works hybrid from Gurugram, collaborating cross‑functionally with portfolio leads and regulatory authorities.
What you’ll do
- Collect and prepare dossiers and variation packages
- Update product information texts and maintain RA databases
- Support pharmacovigilance and CMC data evaluation
- Coordinate responses to regulatory authority queries
- Write and review SOPs for the department
- Assist with MDS compliance and escalation of complex issues
What you’ll bring
- Pharmacy, Chemistry or Biomedical degree
- 3-5 years regulatory affairs experience in generic pharma
- Familiarity with global registration procedures
- Professional training in regulatory affairs
Skills
Regulatory dossiersVariation packagesPharmacovigilanceCMC evaluationCompliance management
Benefits
- Truly global work environment
- High performance culture
- Ability to make a difference
- Best in class compensation