Senior Manager/Director of Regulatory Affairs
il y a 2 semaines
Great new 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.
You will be the key partner to the local organization for all Regulatory (RA) and some Pharmacovigilance (PV) / Patient Safety matters. The role reports into Regulatory 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.
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
Serve as the nominated PV contact toward the Belgian Health Authority.
A master’s degree in Pharmacy or qualification as a Medical Doctor (required)
Demonstrated experience in pharmaceutical regulatory affairs with good knowledge of local regulatory requirements (experience with EU GVP is valuable)
Mother tongue Dutch and excellent English skills are necessary (French is a plus)
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il y a 2 semaines
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