Regulatory Affairs Manager
|Job Title:||Regulatory Affairs Manager|
|Salary:||£50000 per annum|
|Contact Name:||Jake Thomas|
|Job Published:||September 11, 2020 16:51|
Our client is a leader in the gene therapy field, have developed a unique manufacturing process and now moving into product development to meet unmet medical needs.
They are looking for an ambitious and hands-on Regulatory Affairs Manager to help them deliver on their unique clinical development plan. The role will encompass the opportunity to create a regulatory affairs function and be a significant stakeholder in establishing the development programme moving forward.
In this role you will be the key link between the product development team, production, pre-clinical and clinical teams, alongside the quality and project management teams. You will be responsible for compiling DMFs, Clinical trial applications, IMPDs and INDs. You will take ownership for the relationship with regulatory bodies, leading meetings and driving the relationships to meet the needs of the company.
Our client is looking for candidates who have extensive experience in a regulatory environment, with experience in early clinical development alongside a working knowledge of all stages of clinical development. As our client has a very specialised manufacturing process they will also require experience in compiling IMPDs and working closely with manufacturing teams. Excellent interpersonal skills are required as this role will act as the vital link between a number of areas, bringing together a cross-functional team. The right candidate will need to be highly flexible, prepared to work in a number of different areas and be willing to have an open-minded approach to the fast-paced nature of the team.
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