- Our company supports pharmaceutical companies through all phases of the drug development cycle, from preclinical stage to post-approval follow up.
- We serve customers around the world. In order to further develop our professional services, we’re looking for a REGULATORY PROJECT OFFICER
- You are part of the Services Team that brings tailored and timely services to our customers.
- You are responsible for writing scientific documents and regulatory reports (MAAs, IMPDs, Variations, etc.) and you manage the life cycle of the drug from the preparation of the registration dossier, submission of the dossier towards the European authorities to the launch of the registered drug on the market.
- You ensure full compliance with regulatory requirements. You’re reporting to the Services Business Unit Manager.
- Prepare the administrative module of the registration file and submit towards EU authorities (MRP, DCP, national procedure) for both human as veterinary products
- Write technical customer reports as well as CMC regulatory documentation
- Interpret data scientifically and statistically
- Solve problems and issues by offering practical solutions that are compliant with regulatory requirements
- Follow-up on dossiers after submission till MA obtained
- Remain up-to-date on all new laws and regulations concerning pharmaceuticals and medical devices
- You have a Master’s degree in a chemical or pharmaceutical discipline (bio-engineer, pharmacist, chemist, …)
- You have some experience in submission procedures for MA’s or variations and renewals in Europe (1-2 years), knowledge of human regulatory procedures and experience with veterinary filing procedures is a plus.
- You have experience with eCTD format for regulatory filings or CTD dossier GAP analysis
- Experience with writing the CMC module of regulatory dossiers is advantageous
- You show excellent writing and presentation skills with attention to detail and accuracy
- You’re able to handle multiple projects and to adapt to changing priorities
- You’re a team player
- You’re fluent in English
- You will be working in a highly innovative and challenging environment where we encourage personal development and team play.
- We offer you a competitive salary and benefits package.