Global Regulatory Lead/ Director
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Hobson Prior are currently working with a specialty biopharma organisation who are looking for a Global Regulatory Lead/ Director to join them on a permanent basis in Zurich. This is a unique opportunity to join a growing, capable global team and have a key impact on the GRA infrastructure, culture, and success.
- You will have oversight across all regulatory strategic aspects (CMC, Non-clinical, Clinical) for the development and post market activities for the assigned projects.
- Represent Regulatory on the project team and ensure that regulatory strategy, timing and scope of authority interactions, and submissions align with the project plans.
- Responsible lead for any regulatory related issue, for the project team and SMEs internally, with regulatory authorities and with external stakeholders for his/her assigned projects.
- As part of the multifunctional team, the GRL is a key function to coordinate health authorities' interaction and to compile and maintain Regulatory Documentation in collaboration with designated Subject Matter Experts.
- Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment required.
- Master of Sciences or equivalent.
- Substantial subject matter expertise in regulatory affairs and related activities.
- A minimum of 7+ years in relevant functions in the Pharmaceutical Industry, or equivalent (direct experience with biosimilars is an asset).
- Prior experience in coordination of interactions with health authorities and conducting clinical trials in Europe/US is necessary, along with a working knowledge of the EMA/FDA regulatory environment.
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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