Snr Associate Director / Director (Digital Endpoints)
7 days left
- Experience Level
- Senior Management
Hobson Prior are looking for a Senior Associate Director / Director, Digital Endpoints to join a world-wide pharmaceutical company based in Switzerland where you will work remotely. Our client focuses on providing pioneering medical solutions to improve the quality of people's lives.
- To work as an integral part of the RA Innovation group and ensures compliance with global regulatory requirements and adherence to regulatory internal policies and processes.
- Develops high quality regulatory strategy and health authority engagement plans. Supports HA interactions, including the preparation and finalization of briefing books, rehearsals for HA meetings and responses to HA questions.
- You will provide regulatory leadership on digital endpoint development supporting drug development teams in alignment with company approach. Digital endpoints may involve the use of SaMD, ePRO, eCOA, and sensors and experience with these technologies is preferred.
- Supports key regulatory submissions including CTAs, INDs, 510Ks, PMA, IDEs, NDAs, drug dossiers and device clearance planning processes. Identifies requirements, issues, gaps, and trade-offs affecting optimal and timely registration/clearance., for assigned projects.
- Provides input into the Development Core Data Sheet and Core Data Sheet for digital-technology supported drugs along with the drug regulatory lead.
- Exhibits strong leadership skills.
- Strong communication, collaboration skills, writing and problem solving skills.
- Ability to work independently.
- Fluency in English as a business language. Additional language is an asset.
- Works effectively in a highly matrixed organization, managing expectations and collaboratively working across groups and divisions.
- You will need to have a science based BS or MS with necessary experience and demonstrated capability. Having an advanced degree preferred.
- Have a strong knowledge of regulatory development, submission and approval processes in 1 or more major regions for drugs and medical devices, including digital devices.
- Experienced in leading teams in health authority negotiations and making regulatory submissions.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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