Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs CMC(m/w/x)
Full-timeOn-siteSenior
Eysins
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FRFresenius Kabi SwissBioSim GmbH
Regulatory Affairs Specialist Intern(m/w/x)
Eysins
from CHF 60,000 / year
Full-timeInternshipOn-site
Nejo AI Summary
Preparing Module 1 and electronic documents for marketing authorization applications and variations. Health sciences diploma/degree and basic drug development/registration knowledge required. Transportation and meal allowances, plus 20 days annual leave.
Requirements
- Relevant diploma or degree in health sciences
- Fluent command of spoken and written English
- Basic knowledge of international standards in drug development or registration
- Knowledge in MS Office
- Positive attitude, initiative, and proactivity
- Ability to work independently
- Decisiveness
- Teamwork skills
- Adaptability and flexibility
- Willingness to learn
Tasks
- Administer and coordinate logistical aspects of product lifecycle management
- Prepare Module 1 documents for new marketing authorization applications
- Create electronic documents for New Marketing Authorization Applications
- Prepare documents for administrative, quality, and safety variations
- Handle renewals for marketing authorization applications
- Utilize online platforms like Hermes, Yoda, and Confluence
- Update global regulatory databases
- Submit CPP requests to EMA
- Manage invoices, regulatory fees, and purchase orders
- Assist in preparing contracts and agreements with vendors
- Support the shipment of documents, CDs, and samples
- Assist with regulatory affairs labeling activities
- Conduct literature searches
- Receive training on requested SOPs and IT systems
Education
- Vocational certification
Languages
- English – Business Fluent
Tools & Technologies
- MS Office
Benefits
Additional Allowances
- Transportation allowance
- Meal allowance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Kabi SwissBioSim GmbH 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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FRFresenius Kabi SwissBioSim GmbH
Regulatory Affairs Specialist Intern(m/w/x)
Eysins
from CHF 60,000 / year
Full-timeInternshipOn-site
Nejo AI Summary
Preparing Module 1 and electronic documents for marketing authorization applications and variations. Health sciences diploma/degree and basic drug development/registration knowledge required. Transportation and meal allowances, plus 20 days annual leave.
Requirements
- Relevant diploma or degree in health sciences
- Fluent command of spoken and written English
- Basic knowledge of international standards in drug development or registration
- Knowledge in MS Office
- Positive attitude, initiative, and proactivity
- Ability to work independently
- Decisiveness
- Teamwork skills
- Adaptability and flexibility
- Willingness to learn
Tasks
- Administer and coordinate logistical aspects of product lifecycle management
- Prepare Module 1 documents for new marketing authorization applications
- Create electronic documents for New Marketing Authorization Applications
- Prepare documents for administrative, quality, and safety variations
- Handle renewals for marketing authorization applications
- Utilize online platforms like Hermes, Yoda, and Confluence
- Update global regulatory databases
- Submit CPP requests to EMA
- Manage invoices, regulatory fees, and purchase orders
- Assist in preparing contracts and agreements with vendors
- Support the shipment of documents, CDs, and samples
- Assist with regulatory affairs labeling activities
- Conduct literature searches
- Receive training on requested SOPs and IT systems
Education
- Vocational certification
Languages
- English – Business Fluent
Tools & Technologies
- MS Office
Benefits
Additional Allowances
- Transportation allowance
- Meal allowance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Kabi SwissBioSim GmbH 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.
Not a perfect match?
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