My client is a world-leading pinier, mid-size biotech in the field of Neurology and Advanced Therapies. This is a unique opportunity to lead the late-stage Global development of their blockbuster products.
The position is perfect for a candidate that wants complete ownership of their assigned products, you will be at the forefront of EMA and FDA interactions, responsible for the successful MAA submissions.
-Direct global clinical and non-clinical regulatory strategy
-Direct global regulatory life cycle activities
-Develop and maintain the Core Data Sheet
-Lead EMA and FDA health authority interactions
The ideal candidate
-8+ years experience within Regulatory Affairs
-Global experience, FDA and EMA interactions is a must
-Development experience with Biologic products
-Neurology experience is not a must
-MAA submission experience
If this opportunity is of interest to you, or you would like to hear more details, then please get in touch and we can book a call!