Beschreibung

As a GRA CMC Manager, you will lead the development and execution of global CMC regulatory strategies, ensuring compliance while managing submissions and collaborating with technical teams. This role involves guiding CMC Scientists, preparing essential documentation, and addressing regulatory inquiries to facilitate product approvals.

Anforderungen

• •University degree in natural sciences (BS/BA/MS or equivalent)
• •Degree in Regulatory Affairs advantageous
• •Minimum of 5 years’ experience in biotech or pharmaceutical industry
• •At least 3 years in Regulatory Affairs
• •Sound knowledge in natural sciences with focus on biological medicinal products
• •Basic knowledge of regulatory framework in at least one key region (US, EU, Japan, CH, Australia)
• •Excellent communication skills
• •Project management skills
• •Planning skills
• •Problem solving skills
• •Presentation skills
• •Strong team player
• •Ability to develop constructive relationships with peers and management
• •Strong organizational skills
• •Attention to detail
• •Ability to work with minimal supervision
• •Flexibility to work in a global cross-cultural environment
• •Microsoft Office skills
• •Fluency in English
• •Fluency in local language

Aufgaben

• •Drive global CMC strategies for clinical trial applications
• •Manage regulatory submissions for new product licenses and post-approval changes
• •Serve as the primary regulatory liaison with technical experts
• •Support GMP inspections and ensure inspection readiness
• •Interpret regulatory guidelines and prepare impact assessments
• •Contribute to process improvements in regulatory activities
• •Provide technical guidance to CMC Scientists
• •Maintain content of relevant regulatory dossiers
• •Prepare and review Module 2.3 and Module 3 documentation
• •Ensure timely responses to CMC-related Health Authority questions
• •Compile CMC information for CTAs, INDs, and other submissions
• •Execute timely and compliant regulatory assessments for CMC changes
• •Prepare CMC documentation for tenders and promotional materials
• •Contribute to annual product quality reviews and risk assessments
• •Participate in Global Regulatory Affairs Strategy Teams
• •Represent Global Regulatory Affairs in CMC project teams
• •Develop and implement global CMC regulatory strategies
• •Interface with technical expert departments for project planning
• •Evaluate technical CMC information for regulatory compliance
• •Perform gap analysis and propose remediation strategies
• •Support scheduling and prioritization of CMC submissions

Tools & Technologien