Pharmacovigilance & Regulatory Affairs Manager
3 weken geleden
Location: Netherlands or Belgium, FlandersCurrently, we are looking for a Pharmacovigilance and regulatory affairs manager BeNeLuxJob SummaryResponsible for overseeing Regulatory affairs and Pharmacovigilance activities across the BeNeLux region, acting as the primary local contact for both internal stakeholders (local and global teams) and external partners (National Competent Authorities and consultants). Serves as the designated Local Safety Officer for the BeNeLux, maintaining high standards of patient safety and regulatory integrity.Your role:Act as local single point of contact for global functions in Regulatory Affairs and Pharmacovigilance for the BeNeLuxAct as the Local Safety Officer (LSO) for the Netherlands, Belgium and LuxembourgAct as primary contact for regulatory authorities and for external consultants, ensuring compliance of Product Information, approval of artworks for packaging materials and implementation of aRMMResponsible for creating and keep the local Regulatory affairs and Pharmacovigilance SOPs up to dateResponsible for training of BeNeLux team in local Regulatory affairs and Pharmacovigilance SOPsWork closely together with Pharmacovigilance and regulatory affairs managers within the BNS cluster (BeNeLux Nordics and Switzerland) creating a network of knowledge and international cooperation and supportCollaborate with commercial, medical and market access to realize cross-functional objectivesProfile description:Who are you?Minimum 5-10 years of experience in regulatory affairs and pharmacovigilance within pharmaceutical companyKnowledge of local pharmaceutical legislation for Regulatory in the BeNeLux regionKnowledge of applicable laws and regulations to ensure full complianceKnowledge of Regulatory affairs and Pharmacovigilance activities (act as primary contact for regulatory authorities and for external consultants in the regions, ensuring compliance of Product Information, API, approval of artworks for packaging materials and implementation of aRMM)Proficiency in speaking, comprehending, reading and writing Dutch is required.Proficiency in speaking, comprehending, reading and writing English is required.Proficiency in speaking, comprehending, reading and writing French is a plus.Ability to think strategically & execute tacticallyWhat We OfferA dynamic and growing pharmaceutical environment.An ambitious, successful team to work with.Opportunities for professional growth and development.Competitive salary and benefits package.Why Join Alfasigma:At Alfasigma, we foster a culture where the courage to innovate is key to our success.We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.
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Pharmacovigilance & Regulatory Affairs Manager
3 weken geleden
Utrecht, Nederland Alfasigma VoltijdLocation: Netherlands or Belgium, Flanders Maximaliseer uw kans op een succesvolle sollicitatie door ervoor te zorgen dat uw cv en vaardigheden goed aansluiten. Currently, we are looking for a Pharmacovigilance and regulatory affairs manager BeNeLux Job Summary Responsible for overseeing Regulatory affairs and Pharmacovigilance activities across the BeNeLux...
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Regulatory Affairs
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Utrecht, Nederland TMC VoltijdNetherlands Mechanical Utrecht On-site Do you have experience working as Regulatory Affairs within the medical industry? Your role is key in ensuring product and process standards are up to date. - About The Member Company - We are a global high-tech consultancy company with a team of entrepreneurial engineers, scientists, and digital experts from around...
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Utrecht, Utrecht, Nederland Genmab VoltijdAt Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are...
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Regulatory Strategy Director, Europe
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Utrecht, Nederland Genmab VoltijdA biotechnology company is seeking an Associate Director for Global Regulatory Affairs to oversee European regulatory strategy and clinical trial submissions. The role involves leading regulatory initiatives, preparing strategic documents, and ensuring compliance with European regulations. Candidates should have a scientific background, over 8 years of...
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Regulatory Strategy Director, Europe
2 dagen geleden
Utrecht, Nederland Genmab VoltijdA biotechnology company is seeking an Associate Director for Global Regulatory Affairs to oversee European regulatory strategy and clinical trial submissions. The role involves leading regulatory initiatives, preparing strategic documents, and ensuring compliance with European regulations. Candidates should have a scientific background, over 8 years of...
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Regulatory Strategy Director, Europe
2 dagen geleden
Utrecht, Nederland Genmab VoltijdA biotechnology company is seeking an Associate Director for Global Regulatory Affairs to oversee European regulatory strategy and clinical trial submissions. The role involves leading regulatory initiatives, preparing strategic documents, and ensuring compliance with European regulations. Candidates should have a scientific background, over 8 years of...
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Regulatory Strategy Director, Europe
2 weken geleden
Utrecht, Nederland Genmab VoltijdA biotechnology company is seeking an Associate Director for Global Regulatory Affairs to oversee European regulatory strategy and clinical trial submissions.Lees nu meer over de dagelijkse taken, algemene verantwoordelijkheden en vereiste ervaring voor deze functie door naar beneden te scrollen.The role involves leading regulatory initiatives, preparing...
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Regulatory Strategy Director, Europe
2 weken geleden
Utrecht, Nederland Genmab VoltijdA biotechnology company is seeking an Associate Director for Global Regulatory Affairs to oversee European regulatory strategy and clinical trial submissions. Lees nu meer over de dagelijkse taken, algemene verantwoordelijkheden en vereiste ervaring voor deze functie door naar beneden te scrollen. The role involves leading regulatory initiatives, preparing...
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Associate Director, Global Regulatory Affairs, Strategy
1 week geleden
Utrecht, Utrecht, Nederland Genmab VoltijdAt Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are...
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Regulatory Affairs Specialist
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Utrecht, Nederland Kaleido VoltijdMaking every move matterAt ViCentra, we're on a mission to redefine what's possible in diabetes care. We combine technological innovation with human-centered design to empower people with more freedom, confidence, and life on their terms. Our values; Be Bold, Build Trust, Focus on the Customer and Deliver Excellence drive everything we create and every...
