Associate Director, RA-CMC PAC DM
Core
Manage and author Chemistry, Manufacturing, and Control (CMC) sections for marketed product variations and post-approval change submissions to ensure regulatory file-ability and acceptance.
Role type
Senior IC Regulatory Affairs (RA-CMC) Associate Director
Builds
Regulatory dossiers (CMC sections) for marketed product variations and post-approval changes
Domain
Pharmaceutical regulatory affairs (CMC)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC section authoring, project management, CTD structure knowledge, manufacturing unit operations familiarity, regulatory dossier preparation, electronic submission management, team coaching/mentoring, risk identification, template development
Preferred skills
Supervisory experience, US and international regulatory requirements familiarity, electronic document management systems expertise
Technologies
Electronic document management systems, regulatory business systems
Responsibilities
Independently manage, compile, and author CMC sections of marketed product variations; Develop initial content plans, bundling strategies, and project timelines; Collaborate with functional groups to ensure file-ability and acceptance of CMC sections; Lead business critical programs through coordination of activities and resource management across global programs; Ensure CMC expectations including CTD content and structural requirements are met consistently; Provide usage team guidance and drive updates to submission document templates
Seniority
Senior, hands-on IC with management responsibilities