Regulatory Affairs Director - Clinical role - East Midlands
- Experience Level
Senior / Director of Regulatory Affairs
Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join because the company is a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing, clinical testing and Data Sciences. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
The company has an exciting career opportunity for a Senior / Director of Regulatory Affairs to head up the regulatory function at the site in Nottingham. The Regulatory Affairs department currently consists of a team of 10 regulatory professionals. With a number of direct reports, you will be responsible for strategically leading the Regulatory Affairs department, line managing and inspiring the team, whilst driving continuous quality improvement relating to regulatory processes.
The Regulatory function provides a centralised service coordinating regulatory submissions (CTA applications, ARSAC applications & Research Ethics Committee (REC) submissions) for clinical studies. With the expansion of the business and the acquisition of US facilities, the role will also involve development of regulatory strategies to support US IND submissions.
As the Senior / Director, Regulatory Affairs, you will ensure compliance of the Regulatory Affairs Department with relevant legislation and guidance and support the wider business in providing regulatory strategy and advice for new business.
Main tasks and responsibilities include:
- Formulating and providing strategic direction for the Regulatory Affairs function
- Leading the Regulatory Affairs department
- Overseeing the co-ordination / authoring, compilation and submission of regulatory applications, REC and ARSAC submissions and post-submission activities
- Reviewing documentation required for regulatory applications and REC submissions and providing strategic advice to project teams and sponsors
- Liaising with and negotiating innovative and practical solutions to comments arising from Regulatory Authorities, RECs and ARSAC
- Monitoring of the outcome of regulatory submissions to ensure appropriate learnings are documented and process improvements implemented
- Driving continuous quality improvement initiatives relating to regulatory, Ethics and ARSAC submission processes
- Managing and overseeing the development of the Regulatory Affairs services offered
- Managing regulatory resources
- Supporting the Business Development function in providing expert regulatory and submission advice on clinical trial submission strategies
- Providing other expert regulatory advice and guidance as necessary
The successful candidate will be educated to a minimum degree or higher level in a science discipline coupled with extensive previous regulatory experience in a pharmaceutical company or CRO.
Other skills and experience required:
- Extensive knowledge of regulatory and ethics procedures governing performance of clinical trials in the UK and US and ability to apply this knowledge effectively, including problem solving
- Possess a thorough understanding of wider pharmaceutical regulatory environment relating to registration and maintenance of medicinal products and how these may impact clinical trials strategy and delivery
- Extensive knowledge of relevant regulations & guidance and ability to critically analyse and apply knowledge to develop innovative regulatory solutions to arising issues
- Proven project leadership and innovative problem solving ability
- Be a confident and articulate communicator (both written and verbal), with the ability to convey and present highly complex information to others clearly and logically
- Demonstration of effective communication with regulatory authorities
- Being customer focused and possessing the ability to respond to sponsor requirements
- Experience of effective line management and proven ability to lead, engage and inspire others
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.
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