Hamlyn Williams are currently working with a global pharmaceutical company that is in a big phase of growth. Due to this growth, the company is looking for someone to join the Regulatory Affairs team in Germany.

In this role, you will be responsible for supporting submissions and to be the point of contact with the German authorities around submissions.

The office is based in Cologne but the position can be home-based anywhere in Germany.

The role involves but is not limited to:

• Manage the preparation of regulatory submissions including evaluating analytical/manufacturing, clinical and pre‐clinical data, and preparation of CTD/DMF/QOS/SmPC where required

• Responsible for drafting, compiling and controlling quality and regulatory dossiers for Product Registration and Market Launch initiatives

• Leading document collection and review, the incumbent is responsible for document quality and adherence to applicable regulations in collaboration with the submission and review team(s).

• Perform regulatory impact assessment of CMC relevant changes to ensure continuous compliance with applicable regulations

You need to have the right to work in Germany to be considered for this position.

This is a great opportunity for someone who wants to be hands-on and get great exposure to the regulatory authorities in a fast-growing pharmaceutical company. If you are an experienced Regulatory Affairs professional looking for a new challenge, please get in touch!