Descripción de la oferta
We are looking for an experienced Regulatory Affairs Manager to join Animalcare/Ecuphar on a temporary maternity cover basis. You will take ownership of a portfolio of veterinary pharmaceutical products, ensuring dossiers are maintained, variations are managed, and regulatory compliance is upheld across the EU.
This role is ideal for someone who:
Enjoys hands‑on regulatory work
Is comfortable stepping into an existing portfolio
Wants a 6-month, well-scoped contract with real impact
Key Responsibilities and Accountabilities
Prepare, review, and maintain Part II (Quality), Part III (Safety), and Part IV (Efficacy) sections of veterinary pharmaceutical dossiers
Write and update dossier sections and Detailed & Critical Summaries
Support preparation of new product applications and lifecycle variations
Respond to regulatory authority questions during and after registration procedures
CDMO & Stakeholder Collaboration
Work closely with CDMOs and manufacturing partners to ensure quality documentation meets regulatory expectations
Ensure alignment between marketing authorisations, manufacturing processes, and cGMP requirements
Liaise with internal teams across Regulatory, Quality, Development, and Supply
Lifecycle & Maintenance Activities
Manage variations, renewals, and administrative updates
Maintain regulatory documentation for licensed veterinary pharmaceuticals
Maintain regulatory documentation for distribution products (including artwork coordination and translations)
Contribute to the maintenance and accuracy of the regulatory database
Compliance & Knowledge
Stay up to date with EU veterinary regulations, guidelines, and national procedures
Apply regulatory knowledge pragmatically to support business timelines
Support audits, inspections, or site interactions where required (limited travel)
Key Qualifications & Experience
University degree in a relevant scientific discipline such as Pharmacy, Chemistry, Veterinary Science, Life Sciences or a related field; a postgraduate qualification in Regulatory Affairs or Pharmaceutical Medicine is an advantage.
Several years of proven experience in regulatory affairs for medicinal products, ideally within the veterinary / animal health sector.
Demonstrated hands‑on experience in preparing and maintaining regulatory dossiers (quality, safety, efficacy), including management of marketing authorisation applications, variations, renewals and product information updates.
Experience collaborating with contract manufacturers (CDMOs) and cross‑functional teams (e.g. Quality, Development, Pharmacovigilance, Supply Chain, Commercial).
Competencies: Collaborates, Nimble Learning, Ensures Accountability, Manages Complexity, Decision Quality, Customer Focus.
Skills: Veterinary Regulatory Science & Legislation Expertise – Strong knowledge of EU and national veterinary medicines legislation, EMA/VICH guidance and regulatory procedures across the product lifecycle.
Dossier Development & Lifecycle Management – Proven experience preparing, submitting and maintaining regulatory dossiers (quality, safety, efficacy) including variations, renewals and product information updates.
GxP / cGMP & Quality Compliance – Solid understanding of GxP and cGMP requirements for veterinary medicines and ability to ensure that internal processes and contract manufacturers remain compliant with marketing authorisations.
Proficiency in English is required (reading, writing and speaking). Proficiency in other group’s languages (reading, writing and speaking) will be advantageous.
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