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Job Details

Head Of Regulatory Affairs - Biotech, UK

Company: Barrington James Clinical
Reference: CRBG - HRA
Closing Date: 02 Apr 18
Type: Permanent
Salary (£): Competitive

Job Summary:

For more information, please reach out to me directly: +44 1293 77 66 44


Company: Biotech

Location: TBC

Salary: £150,000 + package


My team and I are in partnership with an exciting biopharmaceutical company that are looking to expand their Global Regulatory Affairs team. Following a successful meeting with the CMO, my team and I have been assigned to find this truly innovative company a ‘Head of Regulatory Affairs’ to be based in the UK. Our client has 2 products entering Phase II 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.

If you are looking to make a move away from a large company, then this company could be the one for you. Due to the exposure to board members and C suite level professionals, you will have the capabilities and power to make real changes to the company’s vision and portfolio.

Key Areas of Responsibility

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

Experience / Qualifications Required

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

For more information, please reach out to me directly:

+44 1293 77 66 44

Barrington James is a uniquely successful specialist life science recruitment company and has recently been recognised as a BEST COMPANY To Work For by the Sunday Times. It has enjoyed an exceptional growth trajectory since its launch in 2002, and is now established in the heartlands of the international pharma, medical devices and healthcare industry with consultant staff already approaching 140, and planned to be 180 by the end of 2017.

Recruitment companies succeed by matching the specific needs of clients with the true capabilities of candidates. We believe there are 2 reasons for our outstanding performance over the past decade, which benefit our clients and our candidates equally; People & Knowledge Barrington James’ exceptional people and their depth of experience are ready to work for you, now.

Apply for this job: Head Of Regulatory Affairs - Biotech, UK

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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