Director of Regulatory Affairs
il y a 2 semaines
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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Specialist regulatory affairs
il y a 2 semaines
Bruxelles, Belgique Panda International Temps pleinPMCF Specialist (Medical Devices / Clinical & Regulatory Affairs) Start Date: ASAP Contract Duration: 12 months (possibility of extension) 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. You will collaborate with cross-functional...
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(Senior) Advisor Public Affairs
il y a 3 jours
Bruxelles, Belgique Future Affairs Temps plein(Senior) Advisor Public Affairs & Strategic Communication Location: Brussels based with travel to Rotterdam (hybrid) Type: Full-time Apply to: info(at)future-affairs.eu Start date: as soon as possible, but latest February/ March 2025 Who Are We Looking For? You are an experienced Public Affairs Professional eager to think big and work with high impact...
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Regulatory Affairs Officer
il y a 2 semaines
Bruxelles, Belgique IQVIA Belux Temps pleinFunctieomschrijving – Regulatory Affairs Officer (RAO) Doel van de functie De Regulatory Affairs Officer (RAO) is verantwoordelijk voor het uitvoeren van diverse Regulatory Affairs‐activiteiten binnen de farmaceutische omgeving. De focus ligt op het registreren, onderhouden en opvolgen van geneesmiddelen, het beheren van dossierwijzigingen en het...
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Public Affairs Director
il y a 3 jours
Bruxelles, Belgique European Plastics Converters | EuPC Temps pleinAbout EuPC European Plastics Converters (EuPC) is the EU-level trade association representing the interests of plastics converting companies in Europe. Based in Brussels, EuPC brings together national plastics associations and European sectoral organisations, representing more than fifty thousands converting companies that supply plastic products into key...
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Regulatory Affairs Officer
il y a 2 semaines
Bruxelles, Belgique IQVIA Belux Temps pleinFunctieomschrijving – Regulatory Affairs Officer (RAO) Doel van de functie De Regulatory Affairs Officer (RAO) is verantwoordelijk voor het uitvoeren van diverse Regulatory Affairs‑activiteiten binnen de farmaceutische omgeving. De focus ligt op het registreren, onderhouden en opvolgen van geneesmiddelen, het beheren van dossierwijzigingen en het...
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EMEA Regulatory Affairs
il y a 7 jours
Bruxelles, Belgique JPMorgan Chase & Co. Temps pleinThe position will also be responsible for deepening relationships with EU based regulators including but not limited to the ECB, ESMA, EBA, and the European Systemic Risk Board. The role would require regular travels, primarily to London and EU countries (approximately 25% of the time). As a Vice President within our EMEA Regulatory Affairs team, you will...
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Director & Chief Compliance Officer
il y a 2 semaines
Bruxelles, Belgique CT19 Temps pleinDirector Regulatory Affairs, Europe Rare Disease Biologics Remote position- time in HQ in Europe will be required for business critical requirements. ** Please note candidates must live in Belgium to be considered ** We are working with a European biotech organisation, who are developing novel therapeutics for a range of rare diseases. We are looking...
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(Senior) Advisor Public Affairs
il y a 3 jours
Bruxelles, Belgique Future Affairs Temps pleinSenior) Advisor Public Affairs & Strategic Communication Type: Full-time You are an experienced Public Affairs Professional eager to think big and work with high impact trailblazers from start-ups to corporates, investors and non-profits. You are an entrepreneurial mind, a self-starter and bring a creative, pragmatic growth-mindset. University-level...
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Director Medical Affairs
il y a 1 semaine
Bruxelles, 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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Head of Public Affairs
il y a 3 jours
Bruxelles, Belgique New ERA - New European Reuse Alliance Temps pleinAbout New ERA The New European Reuse Alliance (New ERA) is a non-profit business association representing organisations that develop, operate and promote reusable packaging across Europe. Our members cover the full reuse value chain, including manufacturing, logistics, washing, digital solutions and service provision, across multiple sectors such as HORECA,...
