Senior Manager Regulatory Affairs CMC(m/w/x)

Deine Aufgaben

• •Define and execute RA-CMC strategy for assigned products
• •Ensure compliance with regulatory systems for biosimilars
• •Evaluate change controls and prepare quality regulatory documents
• •Finalize documents for worldwide submissions for clinical trials
• •Compile M3 sections and other CMC dossier elements
• •Plan and coordinate CMC submissions with regulatory functions
• •Track approvals and provide regulatory input for change implementation
• •Represent RA-CMC team in cross-functional forums
• •Respond to health authority questions aligned with company strategy
• •Collaborate with CMC teams to elaborate timely responses
• •Create comprehensive storylines for submissions
• •Present RA-CMC submissions to health authority assessors
• •Manage externalization of RA-CMC activities as needed
• •Ensure regulatory CMC requirements are met during project development
• •Stay updated on regulatory CMC requirements through surveillance
• •Coordinate implementation of changes in laws or guidance
• •Serve as an interface between company functions
• •Distribute RA-CMC activities within the sub-team and partners
• •Prepare briefing books for regulatory agency meetings
• •Incorporate outcomes of consultations with regulatory authorities into quality development
• •Review study and technology transfer protocols for regulatory sections
• •Maintain and update regulatory filing systems
• •Lead CMC regulatory task forces on assigned projects