Regulatory Affairs Manager – UK
Clintec are actively recruiting for a Regulatory Affairs Manager to join our team here in the UK. The successful candidate would ideally be working office based from our Glasgow HQ however we may also consider candidates working from home based or partially home based elsewhere in the UK
The Regulatory Affairs manager will develop and support the Regulatory Affairs function within Clintec and establish and maintain relevant processes in Regulatory Affairs. The RA Manager will develop and deliver regulatory training, establish and maintain Regulatory Intelligence tools, central (HQ) trackers and guidance documents for clinical trials submissions and maintenance and oversee regulatory and ethics committee submissions; ensuring compliance with relevant guidelines, regulations and SOPs. The RA Manager will act as project team functional lead for study start-up, act as operational liaison between Regulatory Expert Network and Clinical Operations and provide regulatory support and input to business development activities, including but not limited to proposal writing, budget development and bid defense presentations.
Key Responsibilities :
- Develop and implement Regulatory Affairs SOPs. Ensure full compliance with appropriate SOPs in regulatory processes.
- Develop and deliver regulatory training to operational staff as required.
- Management of formal global internal expert regulatory network (alongside Regulatory Director).
- Develop and ensure accuracy of regulatory intelligence tools by regular updates to incorporate relevant changes at both a global and local level.
- Oversee and ensure adequate regulatory input to projects at start-up and during the maintenance phase. Assist PMs and CRAs with regulatory, essential document and site activation issues.
- Act as regulatory project lead on assigned projects and provide strategic advice to clients on regulatory start up processes.
- Development of study specific start up plans to ensure optimal regulatory approval and site initiation
- Responsible for ensuring efficient collection, collation and tracking of core essential study documents required by sites participating in clinical trials.
- Line management responsibilities when assigned direct reports.
- Strong previous experience within Regulatory Affairs
- Experience of clinical trial applications
- Experience of management of global studies
- Regulatory and ethics experience across EU (US and Asia would be beneficial)
- Experience of bid defences and proposals
- Experience of SOP writing and training on regulations to other team members
- Experience of review of regulatory documents eg protocols. ICFs etc.
- BSc/MSc/PhD Qualified
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.