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SpecialismRegulatory Affairs
Regulatory hiring is rarely generic. A CMC lead for biologics and a labelling specialist for a generics portfolio need different profiles. We brief on the submission type first.
Roles we recruit
- Regulatory affairs manager (CMC, labelling, lifecycle)
- Regulatory submissions and eCTD publishing specialist
- Regulatory intelligence analyst
- Regulatory operations lead
- Regional regulatory lead
Skills and systems we screen for
- CMC dossiers (Module 3)
- eCTD authoring and publishing
- Labelling and artwork review
- Variations and lifecycle management
- Veeva Vault RIM and publishing tools
- Health-authority queries
What we ask in the screening call
- Submission types led (NDA, MAA, ANDA, variations)
- Regions and authorities covered
- Product class and lifecycle stage
- Hands-on publishing versus oversight
Regulatory frameworks
Reference points we use when briefing and screening.
- EMA
- FDA
- MHRA
- CDSCO (India)
- SFDA (Saudi Arabia)