CSL Plasma
GRA CMC Manager(m/w/x)
Full-timeOn-siteSenior
Bern
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Global CMC regulatory strategies for biotherapeutics, focusing on immunology and hematology. University degree in natural sciences required. Well-being support.
Requirements
- University degree in natural sciences or equivalent
- Degree in Regulatory Affairs is advantageous
- Sound knowledge in natural sciences
- Focus on biological medicinal products
- Basic knowledge of regulatory framework (US, EU, Japan, CH, Australia)
- Excellent communication skills
- Excellent project management skills
- Excellent planning skills
- Excellent problem-solving skills
- Excellent presentation skills
- Strong team player
- Ability to develop constructive relationships
- Ability to develop effective relationships with peers and management
- Strong organizational skills
- Strong follow-up skills
- Attention to detail
- Ability to work with minimal supervision
- Sound technical judgment
- Sound analytical judgment
- Flexibility for global cross-cultural work
- Microsoft Office skills
- Fluent English
- Fluent local language
Tasks
- Lead global CMC regulatory strategies
- Ensure compliant execution of submissions and changes
- Partner with technical and regulatory teams worldwide
- Drive CMC strategies for clinical trials and product licenses
- Assess and manage CMC, facility, and plasma changes
- Serve as primary regulatory liaison with technical experts
- Support GMP inspections and inspection readiness
- Interpret regulatory guidelines and prepare impact assessments
- Contribute to process improvements
- Provide technical guidance to CMC Scientists
- Deputize for the CMC Team Lead
- Maintain content of relevant regulatory dossiers
- Prepare and review Module 2.3 and Module 3 documents
- Compile facility and equipment information for new product registrations
- Author technical narratives and CMC documentation
- Respond to CMC-related Health Authority questions
- Compile CMC information for CTAs, INDs, and other submissions
- Support timely and compliant regulatory assessments
- Execute CMC changes efficiently
- Prepare CMC information for tenders, PSURs, DSURs, 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
- Evaluate technical and scientific CMC information for compliance
- Perform gap analysis and propose solutions
- Support scheduling and prioritization of CMC submissions
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- local – Business Fluent
Tools & Technologies
- Microsoft Office
Benefits
Mental Health Support
- Well-being support
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Global CMC regulatory strategies for biotherapeutics, focusing on immunology and hematology. University degree in natural sciences required. Well-being support.
Requirements
- University degree in natural sciences or equivalent
- Degree in Regulatory Affairs is advantageous
- Sound knowledge in natural sciences
- Focus on biological medicinal products
- Basic knowledge of regulatory framework (US, EU, Japan, CH, Australia)
- Excellent communication skills
- Excellent project management skills
- Excellent planning skills
- Excellent problem-solving skills
- Excellent presentation skills
- Strong team player
- Ability to develop constructive relationships
- Ability to develop effective relationships with peers and management
- Strong organizational skills
- Strong follow-up skills
- Attention to detail
- Ability to work with minimal supervision
- Sound technical judgment
- Sound analytical judgment
- Flexibility for global cross-cultural work
- Microsoft Office skills
- Fluent English
- Fluent local language
Tasks
- Lead global CMC regulatory strategies
- Ensure compliant execution of submissions and changes
- Partner with technical and regulatory teams worldwide
- Drive CMC strategies for clinical trials and product licenses
- Assess and manage CMC, facility, and plasma changes
- Serve as primary regulatory liaison with technical experts
- Support GMP inspections and inspection readiness
- Interpret regulatory guidelines and prepare impact assessments
- Contribute to process improvements
- Provide technical guidance to CMC Scientists
- Deputize for the CMC Team Lead
- Maintain content of relevant regulatory dossiers
- Prepare and review Module 2.3 and Module 3 documents
- Compile facility and equipment information for new product registrations
- Author technical narratives and CMC documentation
- Respond to CMC-related Health Authority questions
- Compile CMC information for CTAs, INDs, and other submissions
- Support timely and compliant regulatory assessments
- Execute CMC changes efficiently
- Prepare CMC information for tenders, PSURs, DSURs, 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
- Evaluate technical and scientific CMC information for compliance
- Perform gap analysis and propose solutions
- Support scheduling and prioritization of CMC submissions
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- local – Business Fluent
Tools & Technologies
- Microsoft Office
Benefits
Mental Health Support
- Well-being support
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
CSL Behring
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
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