Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs Lead(m/w/x)
Vollzeitnur vor OrtSenior
Eysins
Neuer Job?Nejo!
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FRFresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs CMC(m/w/x)
Eysins
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 - 8 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Fresenius Kabi SwissBioSim GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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FRFresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs CMC(m/w/x)
Eysins
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 - 8 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Fresenius Kabi SwissBioSim GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Fresenius Kabi SwissBioSim GmbH
Branche
Pharmaceuticals
Noch nicht perfekt?
- Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs Lead(m/w/x)
Vollzeitnur vor OrtSeniorEysins - Fresenius Kabi
Sr Director Head Of Global Regulatory Strategy(m/w/x)
Vollzeitnur vor OrtManagementEysins - Fresenius Kabi SwissBioSim GmbH
Regulatory Affairs Specialist Intern(m/w/x)
VollzeitPraktikumnur vor OrtEysinsab CHF 60.000 / Jahr - 206030 Fresenius Kabi SwissBioSim GmbH
Senior Manager Medical Device Program Lead(m/w/x)
Vollzeitnur vor OrtSeniorEysins - Haemonetics S.A.
Scientific Affairs Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenSigny-Avenex