SNE/Scientific Specialist (Pharmaceutical)

TL;DR

SNE/Scientific Specialist (Pharmaceutical): Coordinating GMP inspections and providing regulatory support for medicinal products with an accent on EU pharmaceutical legislation and compliance. Focus on managing quality defects, leading drafting groups for regulatory guidance, and coordinating with EU National Competent Authorities.

Location: Amsterdam, Netherlands. Must be a citizen of an EU Member State, Iceland, Liechtenstein, Norway, Moldova, or Ukraine and currently employed in the public sector.

Company

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

What you will do

• Coordinate GMP inspections with EU NCAs for centrally authorised products.
• Manage quality defects, falsifications, non-compliance statements, and rapid alerts.
• Develop regulatory and procedural guidance documents and provide training.
• Support the GMDP Inspectors Working Group and lead drafting subgroups.
• Liaise with internal and external stakeholders and subject experts across the Agency.

Requirements

• Citizen of an EU Member State, Iceland, Liechtenstein, Norway, Moldova, or Ukraine.
• Currently employed in the public sector (e.g., university, research institute, public hospital, or regulatory body) in EU/EFTA/candidate countries.
• University degree in Life Science (Pharmacy, Medicine, or Biomedical Sciences).
• At least 3 years of professional experience as a GMP inspector.
• English proficiency level C1 and satisfactory knowledge of another EU official language.
• Deep knowledge of EU pharmaceutical legislation and Quality Management Systems.

Nice to have

• Master's degree in Medicine or Life Sciences.
• Experience conducting or being subject to audits under the Joint Audit Programme.
• Project Management skills.

Culture & Benefits

• Meaningful work contributing to public health for 500 million citizens.
• Flexible working arrangements and teleworking options.
• Generous annual leave and official holidays.
• Development opportunities including internal mobility, mentoring, and peer coaching.
• Collaborative, multinational, and multidisciplinary team environment.