Head of Regulatory Affairs job in United Kingdom, LEEDS

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This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Head of Regulatory Affairs for a pharmaceutical company focussed on developing therapeutics from the human gut microbiome. This is a n exciting opportunity with a rapidly growing Leeds based biopharmaceutical company that has 2 products entering Phase II studies and 2 products going into clinical development. This is an opportunity to build and manage the Regulatory Affairs and oversee the Quality Assurance functions for the company on a global basis. The candidate will be based in the company headquarters in Leeds.

Job Responsibilities:

Develop and implement innovative regulatory strategies for products entering and in clinical development
Act as a point person for regulatory agency interactions, including preparation of submissions and regulatory strategy planning
Supervise the Quality Assurance aspects of the company's internal and external manufacturing activities
Managing timelines, resource, budgets and risks and reporting on progress for Regulatory and Quality activities
Work closely with the Clinical, Manufacturing and Project Management functions to ensure smooth overall clinical development programme execution

Skills and Requirements:

Advanced degree in a scientific discipline
At least 8 years' experience in regulatory roles in a pharmaceutical or biotech setting
Experience working directly with MHRA and EMA required (FDA also preferred)
Previous IND and NDA submission experience preferred
Entrepreneurial attitude to identify expedited clinical development pathways a must
Ability to work effectively and independently to fast-moving timelines within a fast-paced working environment
A flexible and collaborative nature

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Badria Kahie on +44 203 8718 094 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.