Make your mark for patients
We are looking for a Regulatory Scientist – International Markets to join us in our Regulatory Affairs team, based in our headquarters in Brussels, Belgium.
About the role
The Regulatory Scientist International Markets is responsible for developing and implanting the international markets regulatory strategy in partnership with international markets country affiliate teams and is the primary regional contact point for the Global Regulatory Lead, affiliates, and other global and regional functions for assigned projects/products.
Who you’ll work with
You will report into the Regulatory Science Lead – International Markets.
What you’ll do
1. Develop and implement the International Markets regional regulatory strategy and plan consistent with the business objectives, inputting regional expertise into the global regulatory strategy and global planning in line with the Regulatory Science Lead International Markets and Global Regulatory Lead for assigned projects/products.
2. Serve as the primary regional point of contact for the Global Regulatory Lead, affiliates, and other functions for assigned projects/products.
3. Responsible for facilitating and coordinating the regulatory regional product/submission team in collaboration with the Global Regulatory Lead for assigned projects/products to ensure that objective priorities are met.
4. Responsible for ensuring that the regional regulatory strategy for the specific product(s), have been negotiated with the regional health authorities and that the regulatory risks, mitigations and overall plans are effectively discussed, endorsed, and communicated as required for assigned projects/products.
5. Maintain awareness of external regulatory environment, new guidelines, and legislation, and share potential impact these activities may have on the product development program.
6. Deliver regulatory submissions in line with agreed strategies and timelines.
Interested? For this position you’ll need the following education, experience and skills :
7. Bachelor’s degree required, master’s degree preferred.
8. Several years pharmaceutical experience with knowledge of assigned regional regulatory procedures and legislation.
9. Experience working with cross-functional and international teams and with knowledge and experience of regional regulatory procedures and legislation related to two or more of the following: drug development, product registration, line extension or license maintenance.
10. Communication and influencing skills – knows when and how to communicate, using strong interpersonal skills and written communications when appropriate and being able to influence key decisions.
11. Strategic and results focused - ability to overcome obstacles and achieve key outcomes, anticipating problems and providing creative solutions.
If you are interested to learn more about R&D within UCB, please find more information here .
RANDATUCB
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!