Role descriptionRole: Regulatory Affairs Manager
Location: Head Office, Berkshire
Therapy Area: Diabetes and Cardiovascular
Salary: Negotiable highly competitive salary depending on experience, bonus, company car and additional package benefits
Role Type: Regulatory Affairs, Regulatory Affairs Manager
This is an exciting opportunity to work as a Regulatory Affairs Manager with responsibility to manage a team of Regulatory Affairs Officers and work within a matrix environment in which to best support the companys regulatory considerations. The role has 2 x Line reports (RA Officers) and reports to the Head of Regulatory Affairs.
In this role you will have responsibility for managing an existing product portfolio where you will develop and maintain a comprehensive understanding of EU regulatory requirements for marketing authorisations and their application in the UK and Ireland, to enable regulatory submissions to be compiled in line with current requirements. Proactively review critical new legislation and guidance documents and disseminate to relevant parties information of importance to the business.
If you are a Regulatory Affairs professional and would like to join us and make a difference, please apply!
Manage the review, preparation, submission and follow-up of regulatory submissions to the UK and / or Irish regulatory authorities, to high standards, to ensure that marketing authorisations are maintained in line with the companys plans and goals.
Develop strategic partnership with the Multi Country Organisation (MCO) Global Business Units to understand their priorities and align regulatory objectives of the MCO regulatory team to support the business. Attend Leadership meetings as required.
Provide strategic input into development of lifecycle strategies for Marketed Portfolio & Strategy Management (MPSM) products, both locally and in conjunction with GRA.
Input into review of promotional and non-promotional materials from a regulatory perspective, as required.
Assist the Head of Regulatory Affairs in developing strategies to optimise the efficient running of the department and to manage the achievement of appropriate registrations. Identify issues which may impact on project timeframes.
Manage the workload and personal development of staff. Supervise and train other regulatory staff within department as required by the Head of Regulatory Affairs.
Empower Life Everyday.
Working across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. With the capabilities and resources to support your aspirations to fulfil your ambitions and be the best you can be.
The company purpose is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global, and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we are not there to try to solve everybodys problems. We want to focus on those areas where we know we are making a difference.