Regulatory Affairs Manager
Regulatory Affairs, Manager, Oncology, EU, specials, unlicensed medicines Officer, Executive Staffordshire
Your new company
This is a rapidly-growing speciality pharmaceutical and Service Company with a unique business model dedicated to delivering the right medicine to the right patient at the right time to improve the quality of people's lives around the world. They are strengthening their Regulatory Affairs team with the permanent employment of a Regulatory Affairs Manager.
Your new role
As Regulatory Affairs Manager you will be have Regulatory responsibility for allocated projects on global licensed products within the company including applications for marketing authorisations in new territories, maintenance of existing licenses, variations to existing licenses, transfer of licenses.
In addition you will provide support for allocated Managed Access programs and support the development of regulatory strategies and provision of regulatory advice internally.
You will be representing the company professionally in external meetings in a variety of contexts such as (regulatory authorities, conferences, business meetings).
You will provide coaching and mentoring in specific areas of expertise to junior members of the department and manage direct line reports and/or external consultants whilst providing the necessary training and support to ensure that they are able to fulfil their roles. You will be able to ensure proper filing of regulatory submissions and correspondence either internally or via external contractors and create and maintain allocated SOPs for Regulatory Affairs.
What you'll need to succeed
In order to be considered for the Regulatory Affairs Manager you must have a minimum of a Bachelor's Degree (or equivalent) in Life Sciences or scientific discipline as well as wide experience and knowledge of Regulatory Affairs with an excellent grounding in European procedures and ideally exposure to medicines access i.e. expanded access/compassionate use/ drug development or RoW experience.
You must have a strong background in Regulatory clinical research and clinical trials and be able to demonstrate the ability to deliver results to the appropriate quality, budget and timeline metrics
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.