You don’t have a candidate area. Click here to create one.
You are here : Home › Job Opening list › Vacancy details
OPERATIONS - ENGINEERING/PRODUCTION
Junior regulatory affairs specialist
Permanent contract
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 StakeholdersInternal: NS Team, Brand Managers, Commercial/Medical/Regulatory Affairs teams, Compliance Manager, ManagementExternal: MDEON, Pharma.be, Betransparent.be, Key External Experts (KEEs)
Life sciences
Education & Qualifications
Required:Master’s degree (preferably in pharmaceutical care or development)Solid understanding of promotional regulations and ethical codesKnowledge of medicine marketing and commercializationProficient in Dutch, English, and FrenchExcellent MS Office skills
Skills & Experience
Required:Quick learnerTeam playerMinimum 2 years’ experience in pharmaceutical/medical device industry (RA, medical, or clinical development)Administrative experienceStrong communication skills
Preferred:Prior experience in a pharmaceutical office-based admin roleExperience in RIP or Compliance
Europe, Belgium, Flanders
1 to 3 years