Global Head of Regulatory Affairs - Established Clinical Stage Biotech - Switzerland
Global Head of Regulatory Affairs - Established Clinical Stage Biotech - Switzerland
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Global Head of Regulatory Affairs - Established Clinical Stage Biotech - Switzerland
Planet Pharma is currently working with an established clinical-stage biotechnology company who are renowned for their work in the immuno-oncology space and developing custom-built protein drugs.
As Global Head of Regulatory Affairs you will be working at Senior Director level to support ongoing and new trials across the US and EU. This position will involve all regulatory affairs responsibilities from beginning to end (from IND submissions onwards). You will also be responsible for:
* Developing and executing regulatory strategies to gain earliest possible regulatory approval in the US and other international markets
* Developing effective working relationships with FDA, EMEA and other regulatory authorities
* Managing and implementing planning, authoring, and submission of high-quality briefing documents and clinical trial applications in the US, EU and APAC
* Providing leadership and training of relevant regulatory requirements to develop teams
This is a really exciting role if you're looking to join an established biotechnology company with some really forward-thinking products on the market and more coming through on the pipeline. You will take full ownership of global regulatory strategies for the company's pipeline products so this is a great role if you're looking for a highly autonomous, impactful position for your career progression.
For this position, our client is looking for someone who has extensive experience across international regulatory affairs. You will also have experience with:
* Global submission experience (IND/BLA/MAA) across FDA, EMA and other international regulatory authorities
* Immuno-oncology experience, or ideally experience with radio-ligand therapies
You must be comfortable with international (US predominantly) travel for this position.
For more information on this position or any similar opportunities, please contact Chanel Hicken on 0044 203 868 1011 or email your updated CV in English to chanel.hicken@planet-pharma.co.uk and we can arrange a time for a confidential discussion.
Seniority level
* Seniority level
Director
Employment type
* Employment type
Full-time
Job function
* Job function
Science
* Industries
Pharmaceutical Manufacturing and Biotechnology Research
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