Associate Principal Scientist, Regulatory Chemistry Manufacturing & Controls (CMC) Product Lead
Core
Develop and implement Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for small molecule or biological products, leading the preparation and submission of CMC dossiers for life-cycle maintenance, original registrations, and post-approval changes.
Role type
Associate Principal Scientist, Regulatory CMC Product Lead
Builds
CMC dossiers and regulatory submission components for product lifecycle management
Domain
Pharmaceutical / Biotechnology / Regulatory Affairs
Required skills
CMC strategy development, global regulatory assessment, dossier preparation, risk identification, change management, stakeholder communication, team leadership
Preferred skills
Post-approval lifecycle management
Technologies
Regulatory submission systems, business process systems
Responsibilities
Serve as CMC Product Lead accountable for regulatory milestones; Lead development of global product regulatory strategy; Execute regulatory strategies by authoring CMC submission components; Provide regulatory leadership for in-license, divestment, and withdrawal; Collaborate on compliant change management; Manage execution of CMC documentation including annual reports and renewals; Assess and communicate regulatory risks; Deliver regulatory milestones across product lifecycle.
Seniority
Senior, hands-on IC with potential team management