Scientific Officer Product Lead

Akkodis; Amsterdam; On-site; EUR 40,000 - 60,000; Full time

Benefits offered by this job

Health insurance

Pension

Team events

Development opportunities

Job summary

A life sciences consultancy is seeking a Scientific Officer Product Lead to support the European Medicines Agency in Amsterdam. This full-time role requires a Master's degree and offers opportunities for professional development. Candidates should have up to 3 years of experience in the pharmaceutical industry and demonstrate strong organizational and communication skills. Benefits include holidays, health insurance, and pension plans.

Qualifications

• Up to 3 years of relevant experience in medicines regulation or pharmaceutical industry.
• Experience in centralized procedures and liaising with authorities.
• Regulatory affairs experience with an ability to analyze and report on scientific matters.

Responsibilities

• Provide scientific coordination and regulatory support for medicinal products.
• Lead document development and provide training.
• Respond to information requests from the EMA.

Skills

Organisational skills

Scientific writing

Proficiency in MS Office

Initiative

Diplomacy

Good judgment

Teamwork

Education

Masters in Medicine or Life Sciences

Job description

Akkodis Amsterdam, North Holland, Netherlands

Overview

Join to apply for the Scientific Officer Product Lead role at Akkodis.

We are Akkodis Life Sciences, offering internal and external projects in QA, QC, PV, RA, R&D, Supply Chain and related fields. This role is with the European Medicines Agency in Amsterdam.

This position is for a Scientific Officer who can strengthen the team at our customer, EMA, in Amsterdam.

Start: ASAP / 01-10-2025. End: 31-03-2026. Deadline to apply: 14/09/2025 00:00.

Employment for 40 hours per week with opportunities to work at innovative and progressing companies. Benefits include holidays, health insurance, pension, team events, and development opportunities.

Role summary

Product Lead in the Office for Vaccines and Therapies for Infectious Diseases, ensuring high quality scientific, regulatory and procedural input throughout the product lifecycle.

Responsibilities

• Provide scientific coordination and regulatory and/or procedural support in the following areas: development, evaluation and surveillance of medicinal products for human or veterinary use; referrals and related procedures; management of requests for scientific advice and parallel scientific advice with other decision makers; preparation of summary reports for orphan designation, paediatric plans, or limited markets classifications.
• Delivery of high-quality product information through assessment of invented names, product information and translations, and training on product information guideline principles.
• Apply EU pharmaceutical legislation to EMA operations as required.
• Lead the development of regulatory and/or procedural guidance documents and provide training.
• Coordinate and supervise Scientific Committee meetings, Working Parties, and related groups.
• Respond to information requests received by the EMA in the scientific field.

Communication and professional contacts

• Communicate non-routine information clearly and professionally, including policy interpretation and handling sensitive matters.
• Maintain regular professional contacts with internal and external stakeholders; influence and negotiate when needed.
• Liaise with internal/external experts; coordinate and support effective communication and relations; prepare communications for allocated procedures; support Scientific Committee meetings.

Experience & Background

• Masters in Medicine or Life Sciences.
• Up to 3 years of full-time professional relevant experience.
• Experience in medicines regulation, pharmaceutical industry, or healthcare/academic settings with exposure to scientific, regulatory, or procedural aspects of medicinal products.
• Experience in centralised procedure and liaising with regulatory/public health authorities.
• Regulatory affairs experience on EU-wide or national procedures; information analysis and reporting on scientific/regulatory matters.
• Clinical experience in a therapeutic field; experience working in a multinational organisation with multiple stakeholders; GLP laboratory exposure is a plus.

Skills & Knowledge

• Organisational skills and scientific writing ability.
• Proficiency in MS Office; knowledge of EU pharmaceutical legislation and regulatory framework.
• Initiative, diplomacy and good judgment; excellent teamwork; ability to follow detailed processes; discretion with confidential information.

What we offer

Full-time employment (40 hours per week) with the opportunity to work at European and multinational settings within Life Sciences. Benefits include holidays, fitness, health insurance, pension, training and development, and career opportunities aligned with your aspirations.

• Temporary contract with potential extension depending on budget.
• Opportunity to work at the European Medicines Agency.
• Work-life balance with 24 to 36 holidays.
• Training, coaching and personal development schemes.
• Career opportunities aligned with your aspirations.

How to apply

Please contact your Akkodis Life Sciences Talent Acquisition Specialist by sending your CV and motivation letter to [e-mail]. Include in your CV the following details:

• Period of education and work experience (dd-mm-yy to dd-mm-yy).
• Whether roles were paid or unpaid; full-time or part-time (%).

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Science

Industries

• Pharmaceutical Manufacturing and Biotechnology Research

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