Regulatory Affairs Manager
il y a 2 jours
Great opportunity for a Regulatory Affairs Manager to join the Belgian affiliate of a mid-size pharmaceutical company that recently acquired new molecules, mainly Orphan Drugs / Oncology. JOB SCOPE: You will be the key partner to the local organization for all Regulatory (RA) and some Pharmacovigilance (PV) / Patient Safety matters. This is a great opportunity to combine both areas of expertise while driving meaningful impact. The role reports into Regulatory Europe and works in close alignment with the Patient Safety Center Manager, as well as other internal and global partners across Medical Affairs, QA, Market Access, Business Units and more. MAIN RESPONSIBILITIES: Oversee essential regulatory activities, including interactions with Health Authorities Ensuring continued maintenance of Marketing Authorizations. Life cycle management of marketed products New registrations Manage potential Early Access Programs. Act as the main point of contact for the Health Authorities to help nurture strong and proactive relationships. Ensure proper handling of safety cases from the Belgian market Support cross-functional PV requests Serve as the nominated PV contact toward the Belgian Health Authority. PROFILE: A master's degree in Pharmacy or qualification as a Medical Doctor (required) Willingness to obtain RIP (Responsible Person for Information & Publicity) qualification Demonstrated experience in pharmaceutical regulatory affairs with good knowledge of local regulatory requirements (experience with EU GVP is valuable) Strategic mindset and ability to understand business needs and manage risks Mother tongue Dutch and excellent English skills are necessary (French is a plus) You are a standout colleague with a high level of dedication and a strong willingness to perform Reside in Belgium OFFER: A diverse, inclusive, and innovative environment where different perspectives are valued. The company thrives on curiosity, creativity, and continuous growth. Market-competitive salary package and fringe benefits CONTACT: If this sounds like the challenge for you, I would love to hear from you Please don't hesitate to apply here or to get in touch with Katleen Broeckhoven at katleen@careforceone.be (please include CV)
-
(Senior) Advisor Public Affairs
il y a 3 semaines
Laeken, 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...
-
Director of Public Affairs
il y a 2 jours
Laeken, Belgique MedTech Europe Temps pleinAbout This Role We are seeking an accomplished Director of Public Affairs to drive MedTech Europe's strategic engagement with European policy makers and other stakeholders. Reporting to the Director General for Corporate Affairs, this senior role offers the opportunity to shape policy positions, build influential partnerships, and position the medtech...
-
Director Medical Affairs
il y a 4 semaines
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...
-
Regulatory and Compliance Procurement Lead
il y a 2 semaines
Laeken, Belgique EPM Scientific Temps pleinJob Title: Regulatory & Compliance Procurement Lead Location: Belgium Contract Type: Freelance - Fixed-Term (18 months) Start Date: ASAP About the Role We are looking for an experienced Regulatory & Compliance Procurement Lead to join a leading medical device company on an 18-month freelance contract. This role is essential for ensuring that all procurement...
-
Coordinator Outreach
il y a 4 semaines
Laeken, Belgique Euroseeds Temps pleinAbout Euroseeds Seed of new and improved plant varieties is the indispensable input for all farming and food production. It is estimated that more than 65% of all productivity gains in agricultural production today is due to the improved genetics of new varieties; and that this share is likely to rise even further in view of limitations on other factors such...
-
Public Affairs Director
il y a 3 semaines
Laeken, 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...
-
Public Affairs Director
il y a 2 semaines
Laeken, 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...
-
Consultant Belgian Public Affairs
il y a 4 semaines
Laeken, Belgique Political Intelligence Brussels Temps pleinPolitical Intelligence Brussels is seeking an experienced Public Affairs consultant with a passion for Belgian public policy to reinforce our team. You will be a trusted advisor to clients mainly active across diverse policy landscapes - such as digital, health and beyond. Your role will involve autonomously managing client portfolios and providing strategic...
-
Consultant Belgian Public Affairs
il y a 4 semaines
Laeken, Belgique Political Intelligence Brussels Temps pleinPolitical Intelligence Brussels is seeking an experienced Public Affairs consultant with a passion for Belgian public policy to reinforce our team. You will be a trusted advisor to clients mainly active across diverse policy landscapes - such as digital, health and beyond. Your role will involve autonomously managing client portfolios and providing strategic...
-
EU Public Affairs Consultant in Digital Policy
il y a 3 semaines
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...
