• Author/review and provide input from a CMC perspective on relevant documents required for clinical (IND/IMPD) and commercial (BLA/MAA) submissions for Biologicals
• Facilitated and/or attended CMC meetings with key stakeholders
• Preparation and review of:
- responses to agency questions
- customer variation submissions
- source documents for customer RoW submissions
• Provide regulatory advice to customers and internal teams for biological projects/support projects
• Prepare briefing documents for agency/customer/project meetings


• Bachelor degree in Life Sciences (Master or PhD preferred)
• Experience in preparing and authoring CMC sections for regulatory documents through product life cycle
• Good understanding of regulatory requirements for biologicals
• Good practical experiences in Regulatory Affairs in a pharmaceutical environment
• Previous experience in CMO/CDMO environment is an advantage
• Fluent in English, German is a plus
• Good communication and interpersonal skills

Additional Information

Internal regulatory support for operation and control e.g.:  
o Understanding of EU, US and other global regulatory requirements to support compliance in all phases of contract manufacturing of biological products
o Support site-specific regulatory documentation and activities
o Maintain transparency of information across regulatory functions
o Provide support for site inspections and audits, improvement and development projects
o Perform Regulatory assessments for deviations and change controls
o Provide support for VCNs and other project team queries, as requested  
o Maintenance of site Facility registrations with regulatory agencies and plant-level documentation (e.g. Site Master File and Japan FMA)
o Creation and maintenance of Drug Master Files as appropriate for site activities