CSL Behring
CMC Specialist(m/w/x)
Full-timeOn-siteExperienced
Bern
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Planning and directing regulatory affairs for biotherapeutics, including permit acquisition and compliance monitoring. 3+ years pharmaceutical regulatory experience required. Well-being support and potential for advanced degree advantage.
Requirements
- Bachelor degree in Life Science or Business
- Advanced degree in Life Science (PhD, MD) or Business (MBA) an advantage
- 3+ years regulatory experience in pharmaceutical industry
- Biologics regulatory experience preferred
- Qualifications/responsibilities may vary by local requirements
Tasks
- Plan and direct regulatory affairs activities
- Monitor regulatory compliance for business operations
- Support development of consistent roles and processes
- Oversee plan development, cost estimates, and schedules
- Acquire necessary permits and approvals
- Monitor regulatory developments and advise management
- Establish positive relationships with government agencies
- Represent the organization before regulatory bodies
- Prepare materials for legal counsel and consultants
- Create and compile registration application documentation
- Maintain regulatory systems and data entry
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
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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Planning and directing regulatory affairs for biotherapeutics, including permit acquisition and compliance monitoring. 3+ years pharmaceutical regulatory experience required. Well-being support and potential for advanced degree advantage.
Requirements
- Bachelor degree in Life Science or Business
- Advanced degree in Life Science (PhD, MD) or Business (MBA) an advantage
- 3+ years regulatory experience in pharmaceutical industry
- Biologics regulatory experience preferred
- Qualifications/responsibilities may vary by local requirements
Tasks
- Plan and direct regulatory affairs activities
- Monitor regulatory compliance for business operations
- Support development of consistent roles and processes
- Oversee plan development, cost estimates, and schedules
- Acquire necessary permits and approvals
- Monitor regulatory developments and advise management
- Establish positive relationships with government agencies
- Represent the organization before regulatory bodies
- Prepare materials for legal counsel and consultants
- Create and compile registration application documentation
- Maintain regulatory systems and data entry
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
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.
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.
Not a perfect match?
- CSL Behring
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Full-timeOn-siteExperiencedBern - CSL Behring
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Full-timeOn-siteExperiencedBern - CSL Plasma
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Full-timeOn-siteSeniorBern - Bavarian Nordic Berna GmbH
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Stability Senior Scientist(m/w/x)
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