Scientific Specialist (GMP)

• Provide scientific specialist expertise, coordination, and regulatory support to the review of manufacturing aspects for human and veterinary medicines and their supply chains across the life-cycle of the medicinal product (e.g., evaluation of marketing authorisations and post-authorisation variations and line extensions, and scientific advice).
• Coordinate pre-approval and post-approval GMP and Plasma Master File (PMF) inspections.
• Coordinate assessment of quality defects, recalls, and notifications of GMP non-compliance, within the EU regulatory network and with international partners when required.
• Contribute to/coordinate scientific and regulatory guideline development in the area of manufacturing, including providing scientific and regulatory input to the GMDP IWG, supporting the building of consensus among members of guideline drafting groups, and contributing to the implementation of new legislation and guidelines, whilst keeping overall objectives to protect patient and animal safety in mind.
• Support collaboration with other regulatory working parties within the EU (e.g., Quality Working Party/Biologics Working Party) and international co-operation on manufacturing and inspection related topics, including the exchange of compliance information with international partners, and promoting inspection reliance.
• Present inspection topics at internal and external fora (e.g., to the agency's management, to the GMDP IWG, and at external conferences).

• Motivated professional with strong GMP expertise.
• Broad understanding of the product lifecycle.
• Ability to balance technical knowledge with strategic thinking.
• Strong communication and organisation skills.
• Ability to work both autonomously and in a team.
• Can drive topics forward, ensuring the views of stakeholders are heard, while also contributing their own expertise.

What they ask

• Enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway.
• Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2).
• Have fulfilled any obligations imposed by applicable laws concerning military service.
• Possess a university degree (minimum of four years) in the field of Life Science or General Sciences (e.g., biology, chemistry, biochemistry, pharmacy, engineering) and at least 9 years’ relevant professional experience after obtaining the relevant degree.
• OR possess a university degree (minimum of three years) in the field of Life Science or General Sciences (e.g., biology, chemistry, biochemistry, pharmacy, engineering) and at least 10 years’ relevant professional experience after obtaining the relevant degree.
• At least 5 years of the professional experience must be relevant to manufacturing/GMP. This experience could be gained from work in the areas of manufacturing of medicinal products for human or veterinary use, quality control, quality assurance, innovative manufacturing and/or GMP inspections/audits, in either pharmaceutical industry or a competent authority.
• Critical review and drafting of scientific and regulatory documents for expert and lay audiences.
• Proficient in the use of modern IT systems, and has the ability to work with, analyse and draw conclusions from large sets of data.
• Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU, including ICH guidelines relevant to the role.
• Presenting scientific or regulatory matters at a high level.
• Competencies: Influencing and persuading (Advanced), Prioritising and organising (Advanced), Scientific evidence management (Intermediate), Scientific product lifecycle and procedure management (Intermediate), Regulatory frameworks and strategy (Advanced), Applied knowledge (Advanced), Adaptability and agility (Intermediate), Coping with pressures and setbacks (Advanced), Analysing and problem-solving (Advanced), Ethics and integrity (Intermediate), Team collaboration (Advanced), Customer centricity (Advanced), Results orientation (Advanced), Communication (Advanced), Cross-cultural sensitivity (Advanced), Continuous learning and self-development (Intermediate).

Nice-to-haves.

• Master’s degree in regulatory science, regulatory affairs, quality, manufacturing, pharmaceutical technology, or quality business leadership.
• Background and/or work experience in the following areas:
• Novel/innovative manufacturing technologies or products (e.g., ATMPs, bedside manufacturing, continuous manufacturing).
• Use of artificial intelligence and/or automation in pharmaceutical manufacturing activities.
• Regulatory affairs (which allows for a clear understanding of GMP and how it interacts with submissions of marketing authorisation application).

• Relocation to the Netherlands to take up duties is mandatory.
• Initial five-year renewable contract.
• Competitive monthly national tax-free salary and household & children’s allowances (where applicable).
• Privileges including expatriation (for expatriate staff) and education allowances (where appropriate) and additional home leave.
• Relocation assistance.
• Excellent health insurance scheme and social benefits.
• Retirement Pension Plan.