Regulatory Strategy Lead
Vor 6 Tagen
ALTOGEN is a swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to expert consultants with strong development potential, whom we support in their professional goals. To strengthen our team in **Switzerland**, we are looking for a **Regulatory Strategy Lead (M/F/x).** **ABOUT THE JOB**: - Develop, implement, and sometimes lead regional regulatory strategies to ensure efficient product development and timely approvals. - Assess and communicate the potential for success of regulatory strategies, aligning with program objectives. - Provide regional strategic and tactical guidance to teams, ensuring full regulatory compliance throughout development programs. - Lead regional regulatory teams and represent the EUCAN region in global project meetings. - Manage regulatory submissions for the European region, working with regulatory authorities like the EMA and local agencies to support product approvals. - Partner with market access teams to align on regional strategy and collaborate with national regulatory and health agencies on evidence and value discussions. - Stay updated on regulatory requirements, trends, and emerging issues, providing insights and guidance to global teams. **About you**: - Bachelor’s or advanced degree in a scientific field; advanced degree preferred. - Significant experience in pharmaceutical regulatory affairs, particularly within EU regulations, both in development and post-marketing phases. - Proven expertise in regulatory submissions, working knowledge of EU guidelines, and experience in managing interactions with regulatory authorities. - Strong communication skills, project management, and the ability to work collaboratively within a global, cross-functional environment. - Ability to provide creative, strategic solutions to regulatory challenges and adapt to evolving regulatory landscapes. - Assess and communicate the potential for success of regulatory strategies, aligning with program objectives. - Provide regional strategic and tactical guidance to teams, ensuring full regulatory compliance throughout development programs. - Lead regional regulatory teams and represent the EUCAN region in global project meetings. - Manage regulatory submissions for the European region, working with regulatory authorities like the EMA and local agencies to support product approvals. - Partner with market access teams to align on regional strategy and collaborate with national regulatory and health agencies on evidence and value discussions. - Stay updated on regulatory requirements, trends, and emerging issues, providing insights and guidance to global teams. **_**_ - *_* **WHAT WE OFFER**: - A permanent contract and innovative projects - An attractive remuneration policy - Personalized management and continuous learning to develop your career - Great team spirt and an integration within the "Tribe" **Job Types**: Full-time, Permanent Schedule: - Monday to Friday Work Location: In person **Job Type**: 100% Schedule: - Day shift Work Location: In person
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Global Program Lead, Global Regulatory Affairs
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Lausanne, Schweiz Debiopharm VollzeitDescription Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to...
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Global Clinical Development Lead
vor 2 Wochen
Lausanne, Schweiz Nestle Operational Services Worldwide SA Vollzeit**Position Snapshot** Location: Nestlé Health Science Lausanne, Switzerland Company: Nestlé Health Science Act. Rate: Full-Time Act. Rate 100% Type of contract: Permanent contract **What we offer at Nestlé** Flexible work policies in terms of core hours and working from home. Please talk to us during the recruitment process about what flexibility could...
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Lausanne, Schweiz SHQ Medtronic Int. Trading Sàrl VollzeitA global healthcare technology leader is seeking a Regulatory Affairs Specialist in Lausanne, Switzerland. This role involves coordinating regulatory submissions, ensuring compliance with Swiss medical device regulations, and leading product submissions. Candidates should have a Bachelor's degree in a relevant field and possess 2-5 years of medical device...
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Regulatory Affairs Specialist
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Lausanne, Schweiz SHQ Medtronic Int. Trading Sàrl VollzeitAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic is hiring a Regulatory Affairs Specialist responsible for operating as an established,...
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Lausanne, Waadt, Schweiz Artefact Vollzeit CHF 120'000 - CHF 180'000 pro JahrWho/What is Artefact? Artefact is a next-generation strategy and data consulting firm dedicated to transforming organizations through data and AI. We combine the rigor of top-tier strategy consulting with deep expertise in data, digital, and analytics to help clients achieve tangible business impact. With 1,800 consultants, data scientists, and engineers...
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Lausanne, Waadt, Schweiz Artefact Vollzeit CHF 120'000 - CHF 180'000 pro JahrWho/What is Artefact?Artefact is a next-generation strategy and data consulting firm dedicated to transforming organizations through data and AI. We combine the rigor of top-tier strategy consulting with deep expertise in data, digital, and analytics to help clients achieve tangible business impact.With 1,800+ consultants, data scientists, and engineers...
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Regulatory Affairs Specialist
Vor 3 Tagen
Lausanne, Schweiz Medtronic VollzeitA Day in the Life Medtronic is hiring a Regulatory Affairs Specialist responsible for operating as an established, productive individual contributor who works independently on moderately complex projects with general supervision. In the position, you will set objectives for your own work to align with broader project goals and actively contribute to key...
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Regulatory Affairs Specialist
vor 13 Stunden
Lausanne, Schweiz SHQ Medtronic Int. Trading Sàrl VollzeitAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeMedtronic is hiring a Regulatory Affairs Specialist responsible for operating as an established,...
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Regulatory Affairs Specialist
Vor 4 Tagen
Lausanne, Waadt, Schweiz Medtronic Vollzeit CHF 120'000 - CHF 180'000 pro JahrAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeMedtronic is hiring a Regulatory Affairs Specialist responsible for operating as an established,...
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P2516 - Clinical Development Quality Team Lead
Vor 6 Tagen
Lausanne, Schweiz Debiopharm Vollzeit**_At Debiopharm, every step we take is guided by one purpose: improving the lives of people affected by cancer and infectious diseases. As a privately-owned Swiss biopharmaceutical company, we’re driven by science, but above all, by the people behind every treatment — the patients and their families._** **_ Through our unique “development only”...
