Senior Strategist - Regulatory Affairs (CMC)
Core
Manage regulatory strategies and submissions for new product registrations, post-approval changes, and line extensions in the EU and CIS regions, focusing on CMC modules and herbal product development.
Role type
Senior Regulatory Strategist (CMC)
Builds
Regulatory applications and strategies for new product launches and tender support
Domain
Life Sciences / Pharmaceuticals / Herbal Products
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC module writing (2 & 3), regulatory strategy development, product lifecycle management, health authority relationship management, formulation review, labeling compilation, PQR writing, regional regulatory compliance (EU/CIS)
Preferred skills
RAPS certification, herbal product development background
Technologies
Regulatory tracking tools, SOPs
Responsibilities
Prepare and submit new product registrations and post-approval submissions; review and write CMC modules 2 and 3; execute regulatory strategies aligned with business plans; manage product lifecycle; ensure adherence to timelines and quality parameters; review formulations, ingredient lists, and claims; compile and review labeling components; maintain regulatory work processes and tracking tools.
Seniority
Senior, hands-on IC
