FSP Regulatory Affairs Specialist - CMC Compliance Officer client dedicated
Core
Ensure CMC compliance and manage change control, deviations, and regulatory commitments for biotech assets across global markets.
Role type
Regulatory Affairs Specialist (CMC Compliance)
Builds
Compliance documentation, change control trackers, deviation management systems, and regulatory commitment timelines.
Domain
Biotechnology / Pharmaceutical Manufacturing / Regulatory Compliance
Deliverable
Dashboards & analysis
Required skills
CMC project management, regulatory submissions, technical writing, GMP knowledge, ISO 13485 familiarity, change control management, deviations management, annual reporting, stakeholder coordination, data extraction and tracking
Preferred skills
Quality management, regulatory databases, document management systems, medical device regulations (EU MDR/IVDR, FDA)
Technologies
Microsoft Office (Word, Excel, PowerPoint), regulatory databases, document management systems
Responsibilities
Maintain change control trackers and coordinate implementation dates; manage the Change Control Review Board; establish and maintain deviation trackers; draft and review annual compliance reports; map and track health authority commitments; coordinate excipient supplier selection for pharmacopoeia compliance.
Seniority
Individual Contributor, entry-to-mid level