Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs Lead(m/w/x)
Vollzeit
Senior
Keine Angabe
Eysins
FR
Fresenius Kabi1 Monat
Sr Director Head Of Global Regulatory Strategy(m/w/x)
Management
Vollzeit
Keine Angabe
1262 Eysins
Nejo KI-Zusammenfassung
In this role, you will lead global regulatory strategies for biosimilars, guiding submission processes and ensuring compliance. Your day-to-day responsibilities will involve collaborating with teams, managing regulatory interactions, and developing staff to meet ambitious goals.
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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
Bachelor-Abschluss
Berufserfahrung
15 Jahre
Deine 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
Sprachen
Englisch – verhandlungssicher
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