Regulatory Affairs Manager
Solliciteren
Plaats
Brussel1000
Brussel
België
Contract
Vooltijds, Onbepaalde duurDatum gepubliceerd
2026-02-13Online to:
2026-04-14EUR 20.00 HOUR
Regulatory Affairs Manager
- CareForce One
- Brussel
- 2 dagen geleden
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 (please include CV)
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 (please include CV)
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