Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs Lead(m/w/x)
Vollzeitnur vor OrtSenior
Eysins
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FRFresenius Kabi
Sr Director Head Of Global Regulatory Strategy(m/w/x)
Eysins
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Global regulatory strategy for biosimilar development, managing dossiers and Health Authority interactions. 15+ years international regulatory experience, including biosimilar submissions and team leadership, required. Extensive international collaboration and strategic decision-making.
Anforderungen
- Bachelor's Degree in life science or related disciplines
- At least 15 years in international regulatory
- Experience in people management and driving high performing teams
- Ambition and ability to challenge the status quo
- Experience in managing international or regional regulatory submissions
- Experience in working in development project teams
- Experience in leading regulatory agency interactions
- Experience in preparation and coordination of regulatory strategy plans
- Experience in biological development
- Experience in CTA requirements
- Capability to manage a number and range of projects
- Excellent written and verbal communication skills
- Understanding of Regulatory Affairs contribution to Pharma business
- Excellent organizational skills and self-motivated
- Attention to details and strategic thinking
- Ability to lead regulatory subteam and work in teams
- Autonomous, goal-oriented and pragmatic
- Strong customer-orientation and communication skills
- Fluent command of verbal and written English, additional language skills preferred
Aufgaben
- Provide global regulatory leadership for biosimilar development
- Manage submission-related documents and regulatory data for biosimilars
- Lead preparation and rehearsal for meetings with Health Authorities
- Develop and manage the submission strategy for biosimilar dossiers
- Ensure compliance with Fresenius Kabi regulatory procedures
- Establish regulatory storylines for interactions with authorities
- Collaborate with Regulatory Operations to implement supportive technologies
- Guide market units in interactions with local health authorities
- Map regulatory constraints for life cycle management
- Contribute to wave 2 launch prioritization
- Support the Global Launch Readiness team with regulatory insights
- Develop and maintain a capable regulatory staff
- Coordinate subordinate activities and career development
- Participate in external regulatory committees and trade associations
- Provide guidance in internal management committees
- Lead a team of Regulatory Affairs Leads
- Set ambitious goals and prioritize team tasks
- Serve as back-up for the head of RA biosimilar
- Assess regulatory aspects of due diligence activities
- Lead the Regulatory Sub-team
- Act as Regional Lead based on location for regulatory responsibilities
- Manage the regulatory submission process to approval
- Recommend submission readiness
- Stay updated on the current regulatory environment
- Interface with other regulatory groups and company functions
- Drive interactions with third-party collaborators
- Perform additional tasks to achieve departmental objectives
Berufserfahrung
- 15 Jahre
Ausbildung
- Bachelor-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 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
Sr Director Head Of Global Regulatory Strategy(m/w/x)
Eysins
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Global regulatory strategy for biosimilar development, managing dossiers and Health Authority interactions. 15+ years international regulatory experience, including biosimilar submissions and team leadership, required. Extensive international collaboration and strategic decision-making.
Anforderungen
- Bachelor's Degree in life science or related disciplines
- At least 15 years in international regulatory
- Experience in people management and driving high performing teams
- Ambition and ability to challenge the status quo
- Experience in managing international or regional regulatory submissions
- Experience in working in development project teams
- Experience in leading regulatory agency interactions
- Experience in preparation and coordination of regulatory strategy plans
- Experience in biological development
- Experience in CTA requirements
- Capability to manage a number and range of projects
- Excellent written and verbal communication skills
- Understanding of Regulatory Affairs contribution to Pharma business
- Excellent organizational skills and self-motivated
- Attention to details and strategic thinking
- Ability to lead regulatory subteam and work in teams
- Autonomous, goal-oriented and pragmatic
- Strong customer-orientation and communication skills
- Fluent command of verbal and written English, additional language skills preferred
Aufgaben
- Provide global regulatory leadership for biosimilar development
- Manage submission-related documents and regulatory data for biosimilars
- Lead preparation and rehearsal for meetings with Health Authorities
- Develop and manage the submission strategy for biosimilar dossiers
- Ensure compliance with Fresenius Kabi regulatory procedures
- Establish regulatory storylines for interactions with authorities
- Collaborate with Regulatory Operations to implement supportive technologies
- Guide market units in interactions with local health authorities
- Map regulatory constraints for life cycle management
- Contribute to wave 2 launch prioritization
- Support the Global Launch Readiness team with regulatory insights
- Develop and maintain a capable regulatory staff
- Coordinate subordinate activities and career development
- Participate in external regulatory committees and trade associations
- Provide guidance in internal management committees
- Lead a team of Regulatory Affairs Leads
- Set ambitious goals and prioritize team tasks
- Serve as back-up for the head of RA biosimilar
- Assess regulatory aspects of due diligence activities
- Lead the Regulatory Sub-team
- Act as Regional Lead based on location for regulatory responsibilities
- Manage the regulatory submission process to approval
- Recommend submission readiness
- Stay updated on the current regulatory environment
- Interface with other regulatory groups and company functions
- Drive interactions with third-party collaborators
- Perform additional tasks to achieve departmental objectives
Berufserfahrung
- 15 Jahre
Ausbildung
- Bachelor-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 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.
Noch nicht perfekt?
- Fresenius Kabi SwissBioSim GmbH
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Manager IV Fluids Global Portfolio(m/w/x)
Vollzeitnur vor OrtSeniorEysins - 206030 Fresenius Kabi SwissBioSim GmbH
Senior Manager Medical Device Program Lead(m/w/x)
Vollzeitnur vor OrtSeniorEysins - SUSONITY
Director, Head of Clinical Delivery and Monitoring Unit II(m/w/x)
Vollzeitnur vor OrtSeniorEysins