General Description
The Associate Director of Regulatory Affairs will be responsible for developing and implementing UK regulatory strategies for development programs to secure and maintain the marketing authorization for product(s) in line with business objectives, and in coordination with key internal stakeholders. This will also include oversight and management of commercial products for both UK and Ireland.

Essential Functions of the job:
This individual will lead the UK RA team to manage regulatory aspects of designated compounds (NME/New indications) through all phases of development, registration, post-approval, and lifecycle of the product as detailed below:

• Collaborate with key internal stakeholders to define UK MAA strategy and ensure the regulatory strategy is incorporated and implemented in line with product development objectives
• Manage the content of and prepare regulatory (UK MAA) dossiers. Have knowledge of the content of the EU...