Quality & Regulatory Affairs Manager – Belgium
il y a 2 semaines
Are you ready to take your expertise in Quality & Regulatory Affairs to the next level in a fast-growing healthcare company? Our client is looking for a passionate professional to lead quality management, regulatory compliance, and pharmacovigilance in Belgium.
Join a dynamic and innovative team where your skills will have a direct impact on the safety and success of well-known healthcare brands. Interested? Send your cv to TAEngageBenelux@inizio.com.
Why You Should Apply
Key leadership role in Quality & Regulatory Affairs
Diverse product portfolio – pharmaceuticals, medical devices, dietary supplements, cosmetics & biocides
High-impact position with autonomy & strategic influence
International exposure – collaborate with teams across Belgium and France
Career growth opportunities in compliance & ethics
Your Role & Responsibilities
Quality Management
- Oversee and enhance the Quality Management System (QMS)
- Conduct internal & external audits (authorities, partners, etc.)
- Manage quality incidents, complaints, and CAPAs
- Lead product compliance & batch traceability
- Train internal teams on Quality & Pharmacovigilance
Regulatory Affairs
- Ensure compliance of all pharmaceutical & healthcare products in Belgium
- Handle product registration, renewals & regulatory submissions
- Act as the key liaison for health authorities (FAMHP, etc.)
- Monitor and anticipate regulatory changes affecting the business
Responsible Pharmacist Duties
- Lead batch release for the Belgian market
- Ensure Good Distribution Practices (GDP) compliance
- Oversee pharmacovigilance & medical information as the local RPV
Collaboration & Leadership
- Be the local go-to expert for Quality & Regulatory Affairs
- Work closely with international teams & headquarters
- Support strategic decisions on regulatory & compliance policies
Who We're Looking For
Pharmacy degree with authorization to practice in Belgium
Certified to act as Responsible Pharmacist (RP)
5+ years of experience in Quality & Regulatory roles (preferably in pharma)
Strong knowledge of GDP/GMP & Belgian/EU regulatory frameworks
Excellent problem-solving, analytical, and communication skills
Fluent in French & English and a good knowledge of Dutch
What's in It for You?
Competitive salary & benefits + contract on client payroll
Work in a fast-paced, innovative healthcare environment
Lead high-impact projects with autonomy & influence
Opportunities for career progression into compliance & ethics
Be part of a mission-driven company making a real difference
Location: Brussels region (1 day home office per week)
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