Beschreibung

In this role, you will define and implement regulatory strategies for biosimilars, ensuring compliance while managing submissions and interactions with health authorities. Your daily responsibilities will include collaborating with cross-functional teams and staying updated on regulatory changes to support project development.

Anforderungen

• •Master’s Degree in Life Science or related discipline
• •5-8 years Regulatory Affairs CMC experience in Biotech
• •Experience with biological products, preferably Monoclonal antibodies
• •Experience in managing international regulatory submissions
• •Experience in managing DS and DP site transfers
• •Experience in interaction with regulatory agencies
• •Excellent spoken and written English
• •Excellent written and spoken communication skills
• •Excellent interpersonal skills
• •Good organizational and planning skills
• •Attention to details
• •Ability to work in teams

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