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Regulatory Affairs Project Manager(m/w/x)
Managing product realization and preparing marketing approval submissions for personalized medicine diagnostics. Deep understanding of healthcare regulatory frameworks and 5+ years in related roles required. Global project scope, high autonomy.
Anforderungen
- Bachelor’s or Master’s degree in Life Science, Data Science, or related field, or equivalent experience
- At least 5 years of experience in Regulatory, R&D, Quality, Operations, and/or Clinical roles
- Ability to manage high-complexity work and/or global projects with minimal supervision
- Deep understanding of healthcare regulatory frameworks
- Agile mindset, adept at problem-solving, and skilled in effective communication and stakeholder management
Aufgaben
- Collaborate with internal and external stakeholders
- Manage project and product realization
- Identify and resolve regulatory issues
- Prepare submission packets for marketing approvals
- Interpret regulatory frameworks for strategy development
- Utilize agile principles to streamline activities
- Oversee development of submission and registration dossiers
- Troubleshoot and develop solutions for compliance issues
Berufserfahrung
- 5 - 10 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Noch nicht perfekt?
- Roche Diagnostics Int. AGVollzeitnur vor OrtSeniorRisch-Rotkreuz
- Vaxcyte
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Regulatory Affairs Project Manager(m/w/x)
Managing product realization and preparing marketing approval submissions for personalized medicine diagnostics. Deep understanding of healthcare regulatory frameworks and 5+ years in related roles required. Global project scope, high autonomy.
Anforderungen
- Bachelor’s or Master’s degree in Life Science, Data Science, or related field, or equivalent experience
- At least 5 years of experience in Regulatory, R&D, Quality, Operations, and/or Clinical roles
- Ability to manage high-complexity work and/or global projects with minimal supervision
- Deep understanding of healthcare regulatory frameworks
- Agile mindset, adept at problem-solving, and skilled in effective communication and stakeholder management
Aufgaben
- Collaborate with internal and external stakeholders
- Manage project and product realization
- Identify and resolve regulatory issues
- Prepare submission packets for marketing approvals
- Interpret regulatory frameworks for strategy development
- Utilize agile principles to streamline activities
- Oversee development of submission and registration dossiers
- Troubleshoot and develop solutions for compliance issues
Berufserfahrung
- 5 - 10 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Über das Unternehmen
Roche Diagnostics Int. AG
Branche
Healthcare
Beschreibung
The company is dedicated to advancing personalized medicine and improving patient lives through innovative diagnostics and healthcare solutions.
Noch nicht perfekt?
- Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz - Vaxcyte
Executive Director, Regulatory Affairs(m/w/x)
VollzeitFreelancenur vor OrtSeniorZug, Visp - Cytokinetics
Director, Regulatory Affairs CMC(m/w/x)
Vollzeitnur vor OrtSeniorZug - Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Vollzeitnur vor OrtSeniorZug - Roche Diagnostics Int. AG
Head Environmental Regulatory Affairs(m/w/x)
Vollzeitnur vor OrtSeniorRisch-Rotkreuz