Regulatory Science Lead

il y a 3 jours

Anderlecht, Région de Bruxelles, Belgique UCB Temps plein

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

  • 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.
  • Serve as the primary regional point of contact for the Global Regulatory Lead, affiliates, and other functions for assigned projects/products.
  • 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.
  • 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.
  • Maintain awareness of external regulatory environment, new guidelines, and legislation, and share potential impact these activities may have on the product development program.
  • Deliver regulatory submissions in line with agreed strategies and timelines.

Interested? For this position you'll need the following education, experience and skills:

  • Bachelor's degree required, master's degree preferred.
  • Several years pharmaceutical experience with knowledge of assigned regional regulatory procedures and legislation.
  • 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.
  • 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.
  • 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 R&D at UCB.

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

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on on EMEA- Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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