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.

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 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)