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About the business:
This organisation is well established, have a diverse customer base and are well geared for growth in the coming years. The business supply a range of pharmaceutical products into multiple segments of the healthcare sector and have a strong reputation as one of the leaders within this field
They have a diverse and inclusive culture and you will get the opportunity to not only lead and work alongside a talented regulatory affairs team, but also work cross-functionally with the wider business. The Regulatory Affairs Manager will be an integral part of the the success of the business moving forward, so it is paramount the individual that comes on board is committed to joining a business for the long-term and ready to make a real impact within the company.
About the role:
The Regulatory Affairs Manager will lead the Regulatory Affairs team and is responsible for maintaining/reviewing existing licences as well as implementing new licences. You will have overall responsibility for contributing towards optimum levels of regulatory compliance and supporting the wider business with achieving it's commercial goals
Some of the key responsibilities for the Regulatory Affairs Manager role will involve:
- Leading the Regulatory Affairs team, including all line management responsibilities.
- Ensure that all licences comply with the regulations set by the Regulatory Authority.
- Ensure timely submission of all new licence applications and licence variations by the Regulatory Affairs team.
- Ensure all members of Regulatory Affairs team are adequately trained to perform the tasks required.
- Act as a point of contact for all external stakeholders, including MHRA and licence users.
- Train, mentor and develop members of Regulatory Affairs team.
- Continuously improve the operating standards utilised across the team achieving a continuous improvement culture.
- New Applications/Notifications are submitted in a timely manner, to ensure meeting customer expectations.
- All licence portfolios are continuously up to date with the latest requirements from the regulatory bodies and free from errors.
- Extensive experience working in a leadership/management role within a Regulatory Affairs team in the Pharmaceutical sector.
- Strong knowledge and understanding of regulatory processes in GMP environments.
- A solution orientated individual who focuses on practical resolutions to problems.
- We are open to considering those seeking their first no.1 role in Regulatory Affairs management/leadership - if you are are an aspiring Regulatory Affairs professional and feel ready to take on your first "Head of" role in your career, we want to hear from you!
Please note - ourclient are unable to provide visa sponsorshipand we are therefore only able to accept applications from candidateswho have full right to work in the UK.
Keywords:Head of Regulatory Affairs, Regulatory Affairs Manager, Pharmaceutical, GMP
