Scientific Specialist (Pharmaceutical Quality)

TL;DR

Scientific Specialist (Pharmaceutical Quality): Supporting the Pharmaceutical Quality Office in delivering responsibilities under the Critical Medicines Act with an accent on promoting innovation in manufacturing and strengthening supply chain resilience. Focus on providing scientific and regulatory input for biological medicines, vaccines, and ATMPs.

Location: Relocation to Amsterdam, Netherlands is mandatory.

Salary: €6,961.29 per month (tax-free)

Company

The European Medicines Agency (hirify.global) ensures that medicines available on the EU market are safe, effective, and of high quality for 500 million citizens.

What you will do

• Evaluate Module 2 and 3 quality aspects of human medicinal products across their entire life cycle.
• Manage requests for scientific advice and protocol assistance for biological active substances.
• Develop regulatory guidance documents and provide training on pharmaceutical quality of biologicals.
• Support innovation and advanced manufacturing technologies within the Quality Innovation Group.
• Coordinate Scientific Committee meetings, Working Parties, and Expert Groups.
• Respond to information requests from the hirify.global regarding pharmaceutical quality matters.

Requirements

• Citizen of an EU Member State, Iceland, Liechtenstein, or Norway.
• English: C1 level required; another EU official language at B2 level.
• University degree in Pharmacy, Biology, Chemistry, Biochemistry, Engineering, or related life sciences.
• At least 3 years of professional experience in medicines regulation, pharmaceutical industry, or academia.
• Strong knowledge of EU pharmaceutical legislation and regulatory frameworks.
• Ability to critically review and draft scientific and regulatory documents for expert audiences.

Nice to have

• Knowledge of quality aspects of complex biologicals such as mRNA, gene therapy, and microbiota.
• Experience with platform technologies and ASMF/master file certification schemes.
• Exposure to digitalization in manufacturing and personalized medicine.
• Experience reviewing application dossiers or working with national and international authorities.

Culture & Benefits

• Competitive monthly tax-free salary with household and children's allowances.
• Expatriation and education allowances for eligible expatriate staff.
• Comprehensive relocation assistance to the Netherlands.
• Excellent health insurance scheme, social benefits, and a Retirement Pension Plan.
• Work-life balance through flexible working arrangements and teleworking options.

Hiring process

• Preliminary assessment of eligibility criteria based on the application form.
• Shortlisting through responses to pre-defined questions on competencies.
• Assessments including personality tests (OPQ32) and potentially cognitive reasoning tests.
• Final assessments and potential placement on a reserve list or talent pool.