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Job Details

Head of Regulatory Affairs

Company: ProClinical Ltd
Location: Leeds
Reference: RA.BK.15396
Closing Date: 26 Feb 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

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. ...

Requirements:

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.

Apply for this job: Head of Regulatory Affairs

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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