About the Role

As Regulatory Associate for Disentanglement project, you will be responsible for the regulatory activities associated to formulations transfer between factories in Europe, as per our operating model. This includes, but is not limited to, the internal maintenance of existing portfolio ensuring variations and registration changes are managed properly as part of the product lifecycle.

Your Responsibilities

• Responsible for the regulatory maintenance and delivery of Vestacy formulations transferred, driving consistency, direction and guaranteeing the appropriate resources/expertise in line with the agreed regulatory strategy.
• Manage complex regulatory dossiers due to disentanglement supply project with the aim to achieve a smooth transition in market registrations as per planned timings and existing pipeline compliance.
• Ensuring teamwork in collaboration with other X-functional technical functions like Supply, Safety, Qual...