Regulatory Affairs Director - Nottingham
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- Regulatory Director opportunity
- Leading a team of 10 regulatory professionals
- UK and US focus
- Excellent salary and benefits package
- Dynamic organisation
Are you an experienced Regulatory professional with extensive skills in the CRO or Pharma sector? Would a director role within a fast paced and dynamic organisation, heading up a team of talented regulatory professionals be the next career step for you? If this sounds like you, then we would be delighted to discuss further.
The Director of Regulatory Affairs will head up the regulatory function, currently consisting 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 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.
To be considered for this exciting role, you will have 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
You will 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
The Regulatory Affairs Director will naturally have experience of effective line management and proven ability to lead, engage and inspire others, plus proven project leadership and innovative problem solving ability
You will 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, with being customer focused and possessing the ability to respond to sponsor requirements