Director of Regulatory Affairs
il y a 1 semaine
Director Regulatory Affairs, Europe Rare Disease Biologics EMA Filings Experience Required Remote position- time in HQ in Europe will be required for business critical requirements. ** Please note candidates must live in Belgium to be considered ** About the Company We are working with a European biotech organisation, who are developing novel therapeutics for a range of rare diseases. They have achieved FDA success with a few of their programs, which are now launching into further markets around the world. The portfolio ranges from preclinical to approved products, with multiple new indications currently being explored. We are looking for a Director EU Regulatory Affairs to support on a number of new indications, from early to late phase development & lifecycle management. You will report into the Head of Regulatory Affairs, Europe & International Markets. About the Role This role is an exciting opportunity to join as a key member of the EU & International regulatory team and will be working on a number of indications spanning early & late phase development, and lifecycle management. This will include providing hands-on contributions to MAAs across Europe, including EMA, MHRA and Swiss Medic. The role provides a critical contribution to the development of product regulatory strategies for different indications and will be a key advisor and enabler of successful product launches and commercialization activities. We are looking for candidates who have the below experience: Experience of working on regulatory strategy for late phase compounds- this must include MAA filings to the EMA. EMA experience is required, additional experience with MHRA or Swiss Medic would be beneficial. Experience in orphan drugs or novel first-in-class/ best-in-class indications would be highly beneficial Pharma or biotech experience is required, any experience in rare disease & unmet medical need would be advantageous Strong knowledge in overall drug development & the biopharma regulatory landscape A willingness to work operationally and "hands-on" when required to get tasks completed A desire to work in a biotech environment which can be fast-paced & demanding, whilst also being able to adapt to any strategic changes in pipeline direction. Please apply with an up to date CV for consideration.
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Director Medical Affairs
il y a 5 jours
Laeken, Belgique Nuwhï Temps pleinAbout the role A fast-growing biopharmaceutical organization is expanding its Medical Affairs team and is looking for a Medical Lead for Belgium and Luxembourg. The company is known for its strong focus on biosimilars, biologics and innovative therapies, bringing high-quality and affordable treatments to patients across multiple therapeutic areas. In this...
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EU Public Affairs Consultant in Digital Policy
il y a 1 semaine
Laeken, Belgique Political Intelligence Brussels Temps pleinOur Public Affairs consultancy, based in Brussels is seeking a motivated EU Public Affairs Consultant to reinforce our team. The role involves supporting key corporate clients and associations, within the digital sector. Political Intelligence Brussels is seeking an experienced Public Affairs consultant with a passion for EU Digital public policy to...
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PMCF Specialist
il y a 3 semaines
Laeken, Belgique Panda International Temps pleinPMCF Specialist (Medical Devices / Clinical & Regulatory Affairs) Start Date: ASAP Contract Duration: 12 months (possibility of extension) Location: Diegem, Belgium Job Description As a PMCF Specialist, you will join the Clinical and Regulatory Affairs team at a leading global healthcare company's Medical Devices division in Diegem, Belgium. In this role,...
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Public Affairs and Communications Officer
il y a 3 jours
Laeken, Belgique Cobalt Institute Temps pleinUK or Belgium (home-based) | Regular travel to Brussels and London. Interviews taking place on 16 December in London. Help shape the sustainable future of one of the world's most critical raw materials. At the Cobalt Institute (CI), we're driving global progress by promoting the responsible, safe, and sustainable use of cobalt. Representing the cobalt...
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Financial Regulatory Business Analyst
il y a 3 semaines
Laeken, Belgique The RPO Company Temps pleinWe are looking, on behalf of our client, for a Financial Regulatory Business Analyst to join their consulting team and support leading institutions in the financial services sector. The role focuses on helping clients maintain robust and sustainable compliance while optimizing compliance-related costs. As a Business Analyst, you will act as a key link...
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Government Affairs Manager
il y a 4 semaines
Laeken, Belgique Melbury Wood Temps pleinIn this position, you will lead our client's engagement with European institutions by developing a clear approach to influencing policy and ensuring that their priorities are reflected in major regulatory discussions. Your responsibilities include monitoring policy activity across the EU, evaluating how forthcoming initiatives may affect our client, and...
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Project Manager Regulatory projects
il y a 4 semaines
Laeken, Belgique afarax Temps pleinafarax is looking for a freelance Project Manager Regulatory projects. We need you! The project: Our client in the insurance sector is looking for a Project Manager Regulatory projects to join their team. Function description: Project Leadership & Delivery Manage end-to-end delivery of regulatory projects related to life insurance products, systems and...
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Director of Technology- Blockchain
il y a 3 semaines
Laeken, Belgique IBSC LTD Temps pleinTechnology Director will operate at the intersection of internal stakeholders (ExCo, business lines) and external actors such as FinTechs, regulators, self-authorities, and clients. The position is deeply tied to digital assets, blockchain, and emerging technologies, requiring someone able to both deliver and represent Euroclear's technological vision...
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Commercial Director
il y a 1 jour
Laeken, Belgique NMC sa Temps pleinCommercial Director France & Benelux Based in Belgium – Hybrid (Benelux-France) About NMC NMC is a leading European industrial group, specialized in technical foams, insulation, packaging, and interior design solutions. With about 75 years of expertise, the company is recognized for its innovation, premium quality, and collaborative culture with clients...
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Non Clinical Statistician
il y a 3 semaines
Laeken, Belgique Planet Pharma Temps pleinCMC Statistician (Contractor) – Biopharma Sector We're seeking a CMC Statistician to provide expert statistical consultancy in the context of biological and gene therapy molecules. This role is ideal for someone passionate about applying advanced statistical methods to support CMC development, process optimization, and regulatory submissions in a dynamic...
