Junior regulatory affairs specialist
Junior regulatory affairs specialist
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Job Description
General information
Publication date
28/04/2025Category
OPERATIONS - ENGINEERING/PRODUCTION
Job title
Junior regulatory affairs specialist
Contract
Permanent contract
Job description
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 )
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 Key External Experts (KEEs)
Business Industry
Life sciences
Profile
Education & Qualifications
Required:
Masters 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
Job location
Europe Belgium Flanders
Location
Candidate criteria
Level of experience
1 to 3 years
Required Experience:
Junior IC
Employment Type
Full-Time
