- We put our heart, soul and skills into making a difference for people living with severe disease.
- Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?
- To strengthen our Regulatory Science: Neurology division,we are looking to fill the position of: Regulatory Scientist.
- Serve as primary regional point of contact for the GRL
- Develops / implements the regional regulatory strategy plan
As an 'ethiborative' person and Regulatory Scientist you will contribute by:
- Lead the planning, preparation and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
- Deliver regulatory submissions in line with the applicable regulations, directives and guidelines, and in line with agreed strategies and timelines.
- Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice
- Identify potential regulatory risks to the operational plan, and propose options to mitigate risks.
- Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the GRL.
For this position you’ll need the following education, experience and skills:
- A BSc/ Master’s degree in a relevant Life Sciences discipline
- At least 5 years’ experience (min 5-10 years for the Regulatory Lead) in pharmaceutical regulatory affairs working with cross-functional and international teams
- Knowledge and experience of EU regulatory procedures and legislation related to drug development, product registration, line extension and/or license maintenance.
- Proven successful contribution to delivering regulatory approvals (Regulatory Lead).
Job Segment: Scientific, Neurology, Regulatory Affairs, Scientist, Law, Engineering, Healthcare, Legal, Science