Regulatory Affairs Manager

Proclinical are recruiting a Regulatory Affairs Manager for a biotech corporation. This role is on a contract basis with the ability to work remotely in Europe. **Responsibilities**: - Handle the relationship with the Clinical Research Organisation contracted for some clinical studies. - You will assist with different regulatory proposals to the marketing...

7087 Mylan Pharma GmbH At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...

**Responsibilities**: - Manages regulatory responsibilities associated with the development, support, and deployment of the Company’s non-medical and medical device software products. - Manages development and implementation of regulatory strategies and plans to support the timely introduction of new products and the possible preparation and review of...

Proclinical are recruiting a European Regulatory Affairs - CTA Liaison for a biotech corporation. This role is on a contract basis and is located in Zug. **Responsibilities**: - Collaborate with regulatory affairs consultants/service suppliers on CTA proposals. - Serve as a representative for EU regulatory affairs at cross-functional study management team...

**Key responsibilities for this role will be**: - Planning, coordination and preparation of regulatory submissions to the EMA/MHRA, supporting the Global Regulatory Lead for products post MAA/MHRA approval(s) - Identify and assess regulatory risks associated with assigned project responsibilities and assist in defining strategies to mitigate risks -...

**Job Overview** The position of the Director Regulatory for Combination Product, Medical Devices and Emerging Technologies is based in the HQ of SHL Medical AG in Zug. It holds overall responsibility for Regulatory matters related to combination products, medical devices and emerging technologies. The holder is responsible for establishing applicable...

**Title: Associate Director, International Advertising and Promotion Regulatory Affairs** **Location: Zug or remote (Europe)** **Reporting: Senior Director, International Regulatory Affairs** **Description**: - The Associate Director of International Advertising and Promotion (A&P) serves as an internal expert on industry codes and guidance and...

**Medical Affairs Operations Coordinator - Contract** Location(s): Zug, Switzerland Position type: office-based, in alignment with BlueFlex model* Reporting Line: The position reports to the Associate Director, International Medical Affairs **How will your role help us transform hope into reality?** This position reports into the Associate Director...

**Site Name**: USA - Pennsylvania - Philadelphia, Switzerland - Zug, USA - Massachusetts - Waltham, Waltham, Zug House **Posted Date**: Jun 15 2023 Purpose Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the...

**Site Name**: USA - Pennsylvania - Upper Providence, GSK House, Switzerland - Zug, USA - Massachusetts - Waltham, USA - North Carolina - Durham **Posted Date**: May 16 2024 Purpose Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health...

**Associate Director, International Medical Affairs Operations** Location(s): Zug, Switzerland Level of position: Associate Director Position type: office-based Reporting Line: VP Medical Affairs, International ***How will your role help us transform hope into reality?** ***This position reports into the VP of International Medical Affairs and will...

Quality Systems Manager for Medical Devices We are seeking a Quality Systems Manager to manage the Quality Systems function for a Medical Devices fast-growing business. As the Quality Systems Manager, you will be responsible for ensuring our products comply with all relevant regulatory requirements and standards, **Responsibilities**: - Manage and...

Title**:Vice President, Medical Affairs International** Location(s): Zug, Switzerland Level of position: 12 Position type: office-based, in alignment with BlueFlex model* Reporting Line: The position reports to the SVP, Head of International **How will your role help us transform hope into reality?** Blueprint Medicines is on a journey to becoming a...

We are currently seeking a Project Manager specializing in Software as a Medical Device (SaMD) to join our esteemed client in the pharmaceutical sector. This position offers an exciting opportunity to become part of a dynamic team located in the Zug region. **Responsibilities** Collaborative Engagement: You will actively engage with external partners at...

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**Copper is a digital asset technology company dedicated to helping institutional investors safely acquire, trade, and store crypto assets**: - Built on top of this state-of-the-art custody, ClearLoop is the first solution in the market that overcomes a growing industry challenge; counterparty risk with exchanges. This solution underpins a full prime...

Position Summary: Principal Responsibilities: - Serve as Quality Single Point of Contact on one or more internal Virtual Management Teams consisting of Technical Development, Quality, Planning, Logistics, and Manufacturing Sciences & Technology representatives - Develop, negotiate and maintain Quality Agreements with CMO and ensure compliance with...

On behalf of our client, an international Biotechnology company based in Baar, Swisslinx is looking for a PV Scientist/Senior PV Scientist. This is a contract initially for 12 months (extension possible) with a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment. - Start date: As soon as...

The Senior Clinical Project Manager/Associate Director, Clinical Operations will provide operational expertise within the Research and Development function to ensure timely initiation, execution and reporting of clinical trials in accordance with ICH/GCP and all applicable requirements (including local regulations) to support licensure of products in the...

start date: end date: one year contract, with a high chance on extensionworkload: %location: Rotkreuz (CH)work model: Contracting Your Responsibilities:Responsible for process guidance, process optimization and documentation of various development projects (system and assay) regarding Requirements- and Risk-Management, Configuration Management, Verification...