Working with a globally renowned Clinical Research Organisation based in the heart of London, my client is known for their great work ethos and having a tremendously vibrant company culture that allows for personal and professional growth in many areas.
This company are paving the way to change the culture of CROs globally around the world and are doing so, whilst developing an incredible client base of national and international pharmaceutical companies.
As part of this ongoing success, this client is looking to build out their Senior regulatory department by adding some really experienced and strong-minded candidates to the team. This means that they are now looking for a Senior Director of Regulatory Affairs.
¨ Accountable for development & implementation at a regional and/or global level. This is of regulatory strategy for a product or group of products and for ensuring that the strategy is designed to deliver a rapid approval with good labelling in keeping with the products properties and the needs of the sponsors
¨ Leading and developing a regional and global regulatory strategy that is reflective of domestic and international requirements
¨ Conduct an assessment such as gap analyses, risk planning etc
¨ Act as a single point of contact with the sponsor and internal teams
¨ Be accountable for the delivery of regulatory milestones
¨ Lead the regulatory staff working on a product/project to prioritise objectives that focus on critical activities
¨ Lead regulatory strategy development and updates and ensure appropriate peer review and consultation
¨ Collaborate closely with US regulators to develop global approval strategies
¨ Supervise, develop and mentor regulatory personnel
¨ Advanced degree (PharmD, MD and or PhD preferred)
¨ 6-8 Years’ experience or the equivalent of regulatory drug development (including product approval or launch)
¨ Previous experience helping a team prepare for major health authority interactions (Eg EMA, EOP2 meetings etc)
¨ Pharmaceutical background experience
¨ NOT have been a freelancer or contractor and must be able to work on-site in London
¨ Previous CRO (Clinical Research Organisation) experience
¨ PharmD, MD and or PhD
¨ Basic Salary of £85K - £100K Per Annum
- Clinical Trial Applications