Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs Lead(m/w/x)
Full-timeOn-siteSenior
Eysins
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FRFresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs CMC(m/w/x)
Eysins
Full-timeOn-siteSenior
Nejo AI Summary
Defining regulatory strategy for biosimilars and monoclonal antibodies, preparing worldwide CMC submissions for clinical trials. 5-8 years Regulatory Affairs CMC experience in Biotech with biological products, preferably Monoclonal antibodies, required. Focus on international regulatory submissions and site transfers.
Requirements
- Master’s Degree in Life Science or related discipline
- 5-8 years Regulatory Affairs CMC experience in Biotech
- Experience with biological products, preferably Monoclonal antibodies
- Experience in managing international regulatory submissions
- Experience in managing DS and DP site transfers
- Experience in interaction with regulatory agencies
- Excellent spoken and written English
- Excellent written and spoken communication skills
- Excellent interpersonal skills
- Good organizational and planning skills
- Attention to details
- Ability to work in teams
Tasks
- Define and execute RA-CMC strategy for assigned products
- Ensure compliance with regulatory systems for biosimilars
- Evaluate change controls and prepare quality regulatory documents
- Finalize documents for worldwide submissions for clinical trials
- Compile M3 sections and other CMC dossier elements
- Plan and coordinate CMC submissions with regulatory functions
- Track approvals and provide regulatory input for change implementation
- Represent RA-CMC team in cross-functional forums
- Respond to health authority questions aligned with company strategy
- Collaborate with CMC teams to elaborate timely responses
- Create comprehensive storylines for submissions
- Present RA-CMC submissions to health authority assessors
- Manage externalization of RA-CMC activities as needed
- Ensure regulatory CMC requirements are met during project development
- Stay updated on regulatory CMC requirements through surveillance
- Coordinate implementation of changes in laws or guidance
- Serve as an interface between company functions
- Distribute RA-CMC activities within the sub-team and partners
- Prepare briefing books for regulatory agency meetings
- Incorporate outcomes of consultations with regulatory authorities into quality development
- Review study and technology transfer protocols for regulatory sections
- Maintain and update regulatory filing systems
- Lead CMC regulatory task forces on assigned projects
Work Experience
- 5 - 8 years
Education
- Master's degree
Languages
- English – Business Fluent
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
Senior Manager Regulatory Affairs CMC(m/w/x)
Eysins
Full-timeOn-siteSenior
Nejo AI Summary
Defining regulatory strategy for biosimilars and monoclonal antibodies, preparing worldwide CMC submissions for clinical trials. 5-8 years Regulatory Affairs CMC experience in Biotech with biological products, preferably Monoclonal antibodies, required. Focus on international regulatory submissions and site transfers.
Requirements
- Master’s Degree in Life Science or related discipline
- 5-8 years Regulatory Affairs CMC experience in Biotech
- Experience with biological products, preferably Monoclonal antibodies
- Experience in managing international regulatory submissions
- Experience in managing DS and DP site transfers
- Experience in interaction with regulatory agencies
- Excellent spoken and written English
- Excellent written and spoken communication skills
- Excellent interpersonal skills
- Good organizational and planning skills
- Attention to details
- Ability to work in teams
Tasks
- Define and execute RA-CMC strategy for assigned products
- Ensure compliance with regulatory systems for biosimilars
- Evaluate change controls and prepare quality regulatory documents
- Finalize documents for worldwide submissions for clinical trials
- Compile M3 sections and other CMC dossier elements
- Plan and coordinate CMC submissions with regulatory functions
- Track approvals and provide regulatory input for change implementation
- Represent RA-CMC team in cross-functional forums
- Respond to health authority questions aligned with company strategy
- Collaborate with CMC teams to elaborate timely responses
- Create comprehensive storylines for submissions
- Present RA-CMC submissions to health authority assessors
- Manage externalization of RA-CMC activities as needed
- Ensure regulatory CMC requirements are met during project development
- Stay updated on regulatory CMC requirements through surveillance
- Coordinate implementation of changes in laws or guidance
- Serve as an interface between company functions
- Distribute RA-CMC activities within the sub-team and partners
- Prepare briefing books for regulatory agency meetings
- Incorporate outcomes of consultations with regulatory authorities into quality development
- Review study and technology transfer protocols for regulatory sections
- Maintain and update regulatory filing systems
- Lead CMC regulatory task forces on assigned projects
Work Experience
- 5 - 8 years
Education
- Master's degree
Languages
- English – Business Fluent
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?
- Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs Lead(m/w/x)
Full-timeOn-siteSeniorEysins - Fresenius Kabi
Sr Director Head Of Global Regulatory Strategy(m/w/x)
Full-timeOn-siteManagementEysins - Fresenius Kabi SwissBioSim GmbH
Regulatory Affairs Specialist Intern(m/w/x)
Full-timeInternshipOn-siteEysinsfrom CHF 60,000 / year - 206030 Fresenius Kabi SwissBioSim GmbH
Senior Manager Medical Device Program Lead(m/w/x)
Full-timeOn-siteSeniorEysins - Haemonetics S.A.
Scientific Affairs Specialist(m/w/x)
Full-timeOn-siteExperiencedSigny-Avenex