As a Regulatory Affairs Manager, you will be responsible for preparing and managing regulatory submission dossiers for pharmaceutical products to secure registration in key markets, ensuring deadlines are met and collaborating with clients. You will coordinate variations according to guidelines and provide strategic input on formulation, process, and method development. Achieving milestones related to dossier goals is essential, as is maintaining communication with internal teams, stakeholders, and regulatory authorities. Additionally, you will draft reports for both internal and external use while actively participating in team discussions.

You, as the ideal Regulatory Affairs Manager will recognise yourself in the following:

• Minimum 3 years of experience performing various regulatory affairs duties including writing CMC part within a pharmaceutical company;
• Thorough knowledge of EU and national regulations/guidelines in the field of regulatory affairs;
• Solid understanding of compiling, updating, and amending registration dossiers, as well as electronic submission processes;
• Proficiency in Word, Excel, and (preferably) Adobe Acrobat;
• Detail-oriented, with strong planning, organizational skills, and results-driven mindset

What we offer:

• a challenging and responsible position
• dynamic and growing organisation
• competitive salary and benefits package