Regulatory Affairs CMC Officer H/F Astek

Alsinova, the Astek Group subsidiary offering a complete CRO solution, is recruiting a Senior Preclinical Biostatistician for a project in the pharmaceutical sector.
Your mission (should you decide to accept it):

Working closely with our clients in the Life Sciences sector and reporting to the Regulatory Affairs Manager, you will be responsible for CMC-related regulatory activities across the lifecycle of pharmaceutical products.

You will play a key role in ensuring the regulatory compliance of technical documentation (CTD Module 2 and 3), defining submission strategies, and coordinating with both internal teams and health authorities.

Your daily activities will be:

- Analyze CMC regulatory requirements for each product or submission
- Contribute to the development and execution of CMC regulatory strategies
- Monitor and implement CMC regulatory intelligence and guidance updates
- Prepare and write renewal dossiers (MAA - Marketing Authorization Applications)
- Draft the CMC sections of Module 2 and 3 in CTD format
- Ensure consistency and compliance of the full submission package
- Prepare and submit marketing authorization applications (new, variations, renewals)
- Interact with Health Authorities and stakeholders throughout submission processes
- Gather necessary data and documents from technical departments
- Support internal teams with CMC regulatory guidance

Your future team:

You'll join a committed, collaborative and agile regulatory team that values mutual support, scientific rigor, and ownership.

Our consultants work in an environment that promotes expertise sharing, autonomy, and real career development.

You will benefit from continuous support by your manager and a solid onboarding process to ensure a smooth integration.