Senior Scientist, Regulatory Affairs - Chemistry Manufacturing & Controls (CMC)
Core
Implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for small molecule or biological products and preparing regulatory CMC dossiers for commercial products.
Role type
Senior Scientist, Regulatory Affairs (CMC)
Builds
Regulatory CMC dossiers, post-approval supplements, annual reports, and responses to health authority questions
Domain
Pharmaceutical / Biotechnology / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory CMC strategy, global regulatory requirements assessment, CMC submission documentation, change management, risk assessment and mitigation, product lifecycle management, scientific rationale evaluation, pharmaceutical manufacturing knowledge, analytical testing knowledge, quality assurance knowledge
Preferred skills
Direct experience in Regulatory CMC, Advanced degree (MS, MBA, Ph.D., PharmD), Biological/pharmaceutical research experience, Manufacturing experience, Testing experience
Technologies
None stated
Responsibilities
Provide input to global product and project regulatory strategies by performing assessments of CMC changes; Execute regulatory strategies by leading the development, authoring and review of CMC submission components; Liaise with Organon Manufacturing & Supply colleagues and external partners to support compliant execution of change management; Assess and communicate potential regulatory risks and propose mitigation strategies; Deliver all regulatory milestones for assigned products across the product lifecycle; Identify and communicate potential regulatory issues to Organon Regulatory CMC management
Seniority
Senior, hands-on IC