Principle, Commercial Regulatory Affairs
vor 1 Tag
JOB SUMMARY:The Principal Regulatory Affairs Specialist is part of the Novocure Global Regulatory Affairs (RA) team. In this role, you will be a critical interface between regulatory strategy and commercial execution, ensuring that launch readiness, indication expansion initiatives, promotional and advertising materials for our medical device products comply with global regulatory requirements. You will work cross-functionally with Marketing, Medical Affairs, Legal, Compliance and other stakeholders to support business goals while upholding high standards of ethical communication and regulatory compliance.This is a full time, hybrid role (3-days in office per week) tied to the Baar, Switzerland office reporting to the Senior Director, Commercial Regulatory Affairs.ESSENTIAL DUTIES AND RESPONSIBILITIES:Regulatory Strategy for Launch: Develop and execute regulatory strategies that enable timely and successful product launches in target markets (e.g., U.S., EU, APAC).Cross-Functional Leadership: Collaborate with Commercial, Marketing, Market Access, Medical Affairs, Supply Chain and Clinical teams to integrate regulatory requirements into go-to-market plans.Market Authorization Planning: Oversee communication and progress of submissions to ensure alignment with commercial launch goals.Labeling and Promotional Review: Ensure product labeling, advertising, and promotional materials meet regulatory standards and support business messaging.Regulatory Intelligence: Monitor changes in global regulations and proactively assess impact on product launch strategies and lifecycle management.Engagement: Serve as the regulatory representative in meetings to ensure alignment with launch-readiness discussions.Compliance and Risk Management: Partner with Legal and Compliance to assess risk in marketing practices and ensure commercial activities comply with regulatory expectations.Training: Provide training to launch team/sales/ DDS's on do's and don'ts in commercialization of product according to label and regulatory requirementsRelease of Product: Ensure smooth market release of product into the markets with clearances and final requests to regulators filed.Importation: In partnership with the regional RA teams, ensure all products meet import/export requirements.QUALIFICATIONS/KNOWLEDGE:Qualifications:Bachelor's degree in a life sciences field required; advanced degree preferred. years of regulatory affairs experience in biotechnology, or medical device industry.Proven experience supporting commercial launches across global markets.Strong understanding of regulatory frameworks (FDA, EU MDR, etc.) 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 .Knowledge: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. Experience with combination products.Demonstrated ability to balance regulatory compliance with business objectives.Prior experience in a matrixed, fast-paced, or launch-phase organization.
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Senior Expert Regulatory Affairs
vor 1 Tag
Zug, Schweiz gloor&lang AG VollzeitShape CMC regulatory strategy for complex biologics in a fast-growing biotech environmentFor a fast-growing, internationally active biotech company focused on biosimilar development, we are currently looking for a Senior Expert Regulatory Affairs with a strong CMC focus. Workplace is Region Zug-Zurich in Switzerland, 3d office required.This is a key role...
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Senior Expert Regulatory Affairs
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Zug, Schweiz gloor&lang AG VollzeitShape CMC regulatory strategy for complex biologics in a fast-growing biotech environmentFor a fast-growing, internationally active biotech company focused on biosimilar development, we are currently looking for a Senior Expert Regulatory Affairs with a strong CMC focus. Workplace is Region Zug-Zurich in Switzerland, 3d office required.This is a key role...
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Senior Expert Regulatory Affairs
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Zug, Schweiz gloor&lang AG VollzeitShape CMC regulatory strategy for complex biologics in a fast-growing biotech environment For a fast-growing, internationally active biotech company focused on biosimilar development, we are currently looking for a Senior Expert Regulatory Affairs with a strong CMC focus. Workplace is Region Zug-Zurich in Switzerland, 3d office required. This is a key role...
