SUSONITY
Associate Director, Regulatory Affairs - Digital Health, Device & Combination Products(m/w/x)
Vollzeitnur vor OrtSenior
Eysins
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FRFresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs Lead(m/w/x)
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Global regulatory leadership for biosimilar development, managing submission dossiers and health authority meeting preparations. 6-8 years international regulatory experience with global submission (US BLA/EU MAA) required. Global project scope, international team collaboration.
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Anforderungen
- Degree in life science or related disciplines
- At least 6-8 years in international regulatory
- Experience in managing international or regional regulatory submissions, normally a full global submission (new product application), preferably US BLA or EU MAA
- Experience in working in development project teams
- Experience in leading regulatory agency interactions including management of the associated documentation and rehearsals
- Experience in preparation and coordination of regulatory strategy plan
- Experience in biological development
- Experience in CTA requirements
- Capability to manage a number and range of projects throughout development
- Excellent written and spoken communication skills
- Excellent interpersonal skills
- Understanding of Regulatory Affairs contribution to Pharma business
- Excellent organizational skills, work independently, self-motivated and proactive
- Attention to details, without losing the overall picture
- Ability to think strategically
- Ability to lead regulatory sub team and work in teams
- Autonomous, goal-oriented and pragmatic
- Strong customer-orientation and strong communication skills
- Fluent command of spoken and written English, additional language skills welcome
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 technology strategies
- Support market units in interactions with local health authorities
- Contribute to wave 2 submission prioritization assessments
- Guide Launch Readiness Plans with regulatory process insights
- Lead the Regulatory Sub-team and Strategic Submission Teams as needed
- Act as Regional Lead for US, Canada, or EU regulatory responsibilities
- Manage the regulatory submission process through to approval
- Coordinate regulatory agency interactions and document preparation
- Provide recommendations on submission readiness
- Stay updated on the current regulatory environment
- Interface with other regulatory groups and company functions
- Perform additional tasks to support regulatory objectives
- Drive collaboration with third-party partners for regulatory tasks
- Mentor Junior Regulatory Affairs Leaders
Berufserfahrung
6 - 8 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Englisch – verhandlungssicher
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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.
Zur Originalanzeige bei Fresenius Kabi SwissBioSim GmbHÜber das Unternehmen
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PharmaceuticalsEysins
Fresenius Kabi is a global healthcare company that specializes in IV fluids and other critical care products.
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