BCF OPEN APPLICATION | Regulatory Affairs/Scientific Officer

Job title:

BCF OPEN APPLICATION | Regulatory Affairs/Scientific Officer

Company:

Akkodis

Job description

OPEN APPLICATION | REGULATORY AFFAIRS / SCIENTIFIC OFFICERLocations: Amsterdam, Leiden, BoxmeerWe 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 responsibilitiesAs 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.

|||CompanyDetail|||What about 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! |||CompanyDetail-endCandidateProfile|||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).

Are you interested in this challenge, or do you want to come in touch?Please contact your Talent Acquisition Specialist of Akkodis by sending your CV or apply via the button on this page. |||CandidateProfile-end|||

Expected salary

Location

Amsterdam, Noord-Holland

Job date

Thu, 22 May 2025 01:10:38 GMT

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