Quality & Regulatory Affairs Manager – Belgium

il y a 2 semaines


Bruxelles, Région de Bruxelles, Belgique Inizio Engage Temps plein

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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