Regulatory Affairs Officer - Niel

Introduction · For our client, a veterinary medicines and feeds company we are looking for a Veterinary Regulatory and Quality officer. Check this great opportunity · Job DescriptionAs a Regulatory Affairs & Pharmacovigilance Specialist, you will play a key role in safeguarding t ...

Functieomschrijving

Introduction
For our client, a veterinary medicines and feeds company we are looking for a Veterinary Regulatory and Quality officer. Check this great opportunity

Job Description

As a Regulatory Affairs & Pharmacovigilance Specialist, you will play a key role in safeguarding the quality, compliance, and safety of veterinary medicinal products across Belgium, the Netherlands, and Sweden.

This is a unique opportunity to work at the intersection of pharmacovigilance, regulatory affairs, GDP quality, and ethical compliance.

Your Key Responsibilitie
1) Pharmacovigilance (PV)
Act as Local/Regional Responsible Person for Pharmacovigilance (LRRP) under the functional supervision of the QPPV.
Ensure effective communication of safety signals, product changes, and critical information to the QPPV.
Maintain the local PV system in full compliance with EU and national regulations.
Collect, assess, and report adverse events within required timelines.
Manage PV deviations and CAPAs.
Prepare for and participate in PV inspections and audits.
Develop and deliver PV training for internal teams and third parties.
Ensure PV agreements/clauses are in place with all relevant partners.
Signal Management
Assess the national benefit–risk profile of veterinary products.
Identify safety concerns and escalate to the global PV team.
Coordinate risk minimization actions and interact with national authorities when needed.

2) Local Regulatory Affairs
Ensure national regulatory compliance and contribute to regulatory strategy.

Manage lifecycle activities:
VRAs, VNRAs, responses to LoQs, updates to product information.
Review and update SPCs, PILs, labels, packaging materials, and RA documentation.
Translate regulatory texts when required.
Support new MA applications for veterinary medicinal products.
Collaborate with authorities and internal stakeholders.
Approve promotional materials for compliance with legislation and marketing authorizations.
Ensure compliant declarations for feed, animal care, and related products.
Prepare RA-related SOPs and documentation.

3) Deontology, Transparency & Publicity (BE/NL)Deontology & Transparency
Provide approvals and guidance on sponsorships, benefits, and gifts to VHCPs and HCOs.

Ensure compliance with:
Mdeon guidelines (including visa filing)
Deontological Code
CAVP – NL marketing code
Support Marketing during setup and follow-up of CRM campaigns.

Prepare and submit annual transparency declarations:
Sunshine Act (BE)
Transparantieregister Zorg (NL)
Manage communication via the shared mailbox

Information & Publicity
Review and approve promotional materials for pharmaceutical and non‑pharmaceutical products.
Approve translated promotional content.
Manage product information published in compendia , FIDIN, Vetindex, website).

Your support responsibilities
Back-up Responsible Person for GDP (BE/NL/SE)

Supporting compliance with Regulation (EU) 2021/1248, HSLF‑FS 2021:95 (SE), and national GDP legislation
Ensure the GDP quality system is implemented and maintained.
Oversee authorized activities and ensure accurate documentation.
Ensure all relevant GDP staff are adequately trained.
Coordinate recall operations and handle customer complaints.
Approve suppliers, customers, and subcontracted activities.
Conduct self-inspections and ensure CAPAs are implemented and effective.
Decide on product disposition (returned, recalled, rejected, falsified).
Approve returns to saleable stock.
Prepare destruction certificates and manage administrative batch release for BE/NL, and SE when required.
Profile

Education:
Master's degree in veterinary science, pharmacy, or biology — Essential

Languages:
Dutch — Essential
English — Essential
French — recommended

Experience:
Minimum 1 year of experience in pharmacovigilance and/or regulatory affairs.

Competencies:
Core Competencies
Continuous Improvement
Communication
Customer Focus
Functional Competencies
Creating a Service Reputation
Technical/Professional Knowledge & Skills
Work Standards
Adaptability

Offer
Join a global animal health player ranked in the top 10 worldwide with a family-owned atmosp
here.
Work in a fun & dynamic team with passionate colleagues who are just as obsessed with animals as you
are.
Enjoy hybrid working with optimal harmony between your work and personal
life.

Your gross salary depends on experience and beside that you will find in the salary package:

A net allowance
Annual bonus
Group insu rance
Health insurance
Mobile phone+ laptop