OPEN APPLICATION Regulatory Affairs / Scientific Officer

We are looking for a proactive Regulatory Affairs / Scientific Officer who thrives at the intersection of scientific insight and regulatory strategy.

Job

We are looking for a proactive Regulatory Affairs / Scientific Officer who thrives at the intersection of scientific insight and regulatory strategy. In this dynamic role, you’ll take ownership of preparing, submitting, and maintaining regulatory dossiers, while contributing to the scientific rationale behind our medicinal products across the EU and international markets.

You'll be a key point of contact between internal teams (R&D, Quality, Manufacturing) and external authorities such as the EMA, national agencies, or health authorities worldwide.

Key responsibilities
As a Regulatory Affairs / Scientific Officer you could/will be responsible for:

Coordinate, prepare, and submit regulatory dossiers (MAAs, variations, renewals) in compliance with EU legislation and international standards.
Draft and review Module 2 summaries and contribute to Module 3 (CMC) content.
Support scientific advice procedures and interact with regulatory agencies (EMA, national authorities, FDA).
Provide internal scientific support on development strategies, formulations, and regulatory changes.
Monitor regulatory updates and ensure timely implementation of relevant changes.
Serve as the primary contact for regulatory and scientific queries from authorities, affiliates, or partners.
Contribute to the development of internal SOPs, templates, and training material.

Profile

What you bring

A university degree in Pharmacy, Medicine, Biomedical Sciences, Chemistry, or a related scientific field.
Minimum of 1 year of experience in Regulatory Affairs (pre: pharmaceutical industry).
Solid knowledge of EU regulatory frameworks, EMA procedures, and ICH guidelines.
Strong skills in scientific analysis, documentation, and regulatory writing.
Experience with regulatory authority interactions is an asset.
Excellent written and verbal communication skills in English.

It is a big plus if you have also have:

Hands-on experience with EMA scientific advice procedures or previous work at a regulatory authority.
Familiarity with biologics, ATMPs, or generic product dossiers.
Certification in Regulatory Affairs.
CMC knowledge or experience with global dossier strategies (e.g., US, Canada, ROW submissions).

Benefits

What do we offer?

Employment for 32-40 hours per week and the opportunity to work at innovative and progressing companies. You will be part of a fast growing Life Sciences team that is represented in different industries (biotech, pharma, food) and present in Life Sciences clusters in The Netherlands.

Temporary contract, depending on the budget the possibility to extend;
Attractive salary;
Work-life balance with 24 to 36 holidays;
Company fitness, health insurance and good pension scheme;
Monthly meetings with your personal Business Manager to talk about your performance, progress and ambitions;
Annual team events;
Options to attend training, coaching and a personal development scheme;
Career opportunities matching your aspirations and development.

Company profile

Who are we, Akkodis?

We are Akkodis. We put the talents, skills and ambitions of our Consultants first. Because we continuously offer you challenging projects, you continue to develop and you can realize your ambitions. This is our view on good employment practices. We, Akkodis Life Sciences, offer you internal and external projects in the field of QA, QC, PV, RA, R&D, Supply Chain and related.

We have +/- 60 Consultants working at the EMA, Astellas, Unilever, Corbion, MSD, Organon, Aspen and many more!