Takeda Development Center Americas, Inc.
Associate Director, Global Regulatory Affairs, Advertising and Promotion(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
Zürich
NO
Novocure Inc1 Monat
Principal Regulatory Affairs Specialist(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
6340 Baar
Nejo KI-Zusammenfassung
As a Principal Regulatory Affairs Specialist, you will play a vital role in ensuring that product launches meet regulatory standards. Your day-to-day responsibilities will involve collaborating with various teams, overseeing submissions, and monitoring regulatory changes to support successful market entry.
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Anforderungen
- •Bachelor’s degree in life sciences
- •7+ years of regulatory affairs experience in biotechnology or medical device industry
- •Proven experience supporting commercial launches across global markets
- •Strong understanding of regulatory frameworks and their commercial implications
- •Demonstrated ability to translate regulatory requirements into actionable business guidance
- •Exceptional leadership, communication, and cross-functional collaboration skills
- •Strategic thinker with a results-driven approach to regulatory problem-solving
- •Attention to detail and excellent communication skills
- •Ability to organize, plan and adjust work assignments while meeting deadlines
- •Familiarity with digital marketing regulations and social media guidance
- •Knowledge of Class II and/or Class III medical devices and combination products
- •Demonstrated ability to balance regulatory compliance with business objectives
- •Prior experience in a matrixed, fast-paced, or launch-phase organization
Bachelor-Abschluss
ODER
Master-Abschluss
Berufserfahrung
7 Jahre
Deine Aufgaben
- •Develop and execute regulatory strategies for product launches
- •Collaborate with cross-functional teams to integrate regulatory requirements
- •Oversee submission communications to align with launch goals
- •Ensure product labeling and promotional materials meet regulatory standards
- •Monitor global regulatory changes and assess their impact
- •Represent regulatory interests in launch-readiness meetings
- •Partner with Legal and Compliance to manage marketing risks
- •Provide training on commercialization do's and don'ts
- •Ensure smooth product market release with necessary clearances
- •Ensure compliance with import/export requirements
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novocure Inc 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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