Takeda Development Center Americas, Inc.
Associate Director, Global Regulatory Affairs, Advertising and Promotion(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
Zürich
TA
Takeda Pharmaceuticals International AG23 Tage
GRA CMC Director - Marketed Products Development Lead(m/w/x)
Management
Vollzeit
Keine Angabe
Zürich
Nejo KI-Zusammenfassung
As the Director of Global Regulatory Affairs CMC Marketed Products Development, you will manage regulatory submissions and lifecycle activities while leading a team to ensure compliance with global regulations. This role involves collaborating with various stakeholders and Health Authorities to enhance communication and decision-making processes.
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Anforderungen
- •BS/BA Degree in a Scientific Discipline, Advanced Degree preferred
- •10+ years pharmaceutical Regulatory CMC experience or equivalent industry experience
- •Experience with active pharmaceutical ingredient/drug substances, small molecules, drug products, biologics, analytical characterization, process scale-up or regulatory registration of products
- •Expert in developing alternate strategies based on guidance/regulations
- •Expert in liaising with Regulatory Agencies as lead in successful Agency Interactions
- •Understanding of scientific principles and regulatory CMC requirements relevant to global drug development
- •Ability to deal with issues of critical importance and provide regulatory advice
- •Able to provide sound strategic advice and enable critical decisions under ambiguity
- •Demonstrate leadership, problem-solving ability, flexibility, and values teamwork
- •Demonstrate strategic enterprise thinking and ability to influence in a complex matrix environment
- •Exercise good judgement in elevating and communicating issues to line management
- •Build and maintain a team environment that inspires and enables progress
- •Expert in CTD authoring and/or review skills throughout the product lifecycle
Bachelor-Abschluss
ODER
Master-Abschluss
Berufserfahrung
10 Jahre
Deine Aufgaben
- •Manage regulatory submissions for global marketing applications
- •Oversee post-approval lifecycle activities for assigned compounds
- •Evaluate change proposals for global regulatory impact
- •Plan global variations and amendments
- •Interpret EMA, FDA, ICH, and WHO regulations for CMC compliance
- •Lead team in establishing CMC content requirements for regulatory submissions
- •Review submission content for compliance with established requirements
- •Communicate developments impacting regulatory success to project teams and stakeholders
- •Provide solutions to prevent recurrence of regulatory issues
- •Interact with international Health Authorities and facilitate agency meetings
- •Stay updated on evolving regulatory CMC requirements
- •Apply regulatory knowledge to projects and support colleagues' development
- •Maintain constructive relationships with colleagues and Health Authority representatives
Sprachen
Englisch – verhandlungssicher
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