Junior regulatory affairs specialist

Context

The Nominated Signatory (NS) team ensures that all scientific and promotional communications to healthcare professionals (HCPs) comply with Belgian and Luxembourg pharmaceutical legislation and ethical codes. They also manage quality systems for medicine samples and ensure transparent reporting of transfers of value to HCPs and healthcare organizations.

Key Responsibilities

Support the Nominated Signatory in:
- Pre-approving promotional and non-promotional materials
- Overseeing events (promotional meetings, advisory boards, etc.) and service fees to consultants
- Managing sponsorships/donations to HCOs and patient   organizations
- Reviewing scientific leaflets and coordinating with Regulatory Affairs
- Submitting data on transfers of value to authorities (FAMHP, Betransparent.be)

Use tools like:
- Microsoft Office
- Veeva CRM & Vault Promomats
- Internal AstraZeneca portals
- Mdeon portal

Internal & External Stakeholders
Internal: NS Team, Brand Managers, Commercial/Medical/Regulatory Affairs teams, Compliance Manager, Management
External: MDEON, Pharma.be, Betransparent.be, Key External Experts (KEEs)

Education & Qualifications

Required:
Master’s degree (preferably in pharmaceutical care or development)
Solid understanding of promotional regulations and ethical codes
Knowledge of medicine marketing and commercialization
Proficient in Dutch, English, and French
Excellent MS Office skills

Skills & Experience

Required:
Quick learner
Team player
Minimum 2 years’ experience in pharmaceutical/medical device industry (RA, medical, or clinical development)
Administrative experience
Strong communication skills

Preferred:
Prior experience in a pharmaceutical office-based admin role
Experience in RIP or Compliance