SNE/Regulatory Affairs Specialist (Veterinary)

TL;DR

SNE/Regulatory Affairs Specialist (Veterinary): Providing regulatory advice and compliance checks for centralised veterinary medicines with an accent on product information and EU legislative changes. Focus on preparing guidance, managing pre- and post-authorisation procedures, and negotiating regulatorily compliant outcomes with stakeholders.

Location: Must be a national of an EU, EFTA Member State, or a candidate country and currently employed in the public sector. Based in Amsterdam, Netherlands (hybrid/teleworking options available).

Company

The hirify.global (EMA) is a decentralized body of the European Union responsible for the evaluation and supervision of medicines to protect public health.

What you will do

• Respond to regulatory queries and prepare guidance, specifically utilizing QRD templates v.9+ for veterinary medicines.
• Provide regulatory support for pre-submission meetings and ongoing authorisation procedures.
• Perform risk-based regulatory compliance checks on formal outputs before transmission to the European Commission.
• Present complex regulatory requirements to stakeholders at CVMP meetings and EMA info days.
• Contribute to internal and external negotiations to reach regulatorily compliant outcomes.

Requirements

• National of an EU, EFTA Member State, or a candidate country.
• Currently employed in the public sector (e.g., university, research institute, public hospital, or regulatory body).
• University degree (at least 3 years) in Veterinary medicine, Life Science, or EU pharmaceutical law.
• Minimum 3 years of experience in regulatory and procedural aspects of veterinary medicines.
• English: C1 level required.
• Another official EU language: B2 level required.

Nice to have

• Master's degree or post-secondary education in regulatory science or affairs.
• Experience as a Regulatory Affairs professional on EU-wide or national procedures.
• Experience working in multinational organisations and managing international stakeholders.
• Working knowledge of the Union Product Database.

Culture & Benefits

• Meaningful work contributing to the protection of animal and public health across Europe.
• Professional development opportunities including internal mobility, mentoring, and peer coaching.
• Strong work-life balance with flexible working arrangements and teleworking options.
• Generous annual leave and official holidays.