Head of Regulatory Affairs

Date Posted: 3/7/2018 Reference: VAC-1004981 Salary: £150000 Location: LEEDS Job type: Permanent Sector: Science | Speciality: Pharmaceuticals Contact: Michael Hogan

I am currently recruiting for a rapidly growing biopharmaceutical company; this company specialises in biotherapeutics and are now looking to bring a new Head of Regulatory Affairs. This is an opportunity to build/manage the regulatory affairs and oversee the quality assurance functions for the company on a global basis.

***What the Head of Regulatory Affairs will do***

+ 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
+ Managing timelines, resource, budgets and risks and reporting on progress for Regulatory and Quality activities
+ Working with Head of IPCG to ensure department tools and processes in relation to IP are adequate and complied with
+ Work closely with the Clinical, Manufacturing and Project Management functions to ensure smooth overall clinical development programme execution

***What the Head of Regulatory Affairs needs***

+ 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
+ Advanced degree in a relevant scientific discipline
+ Entrepreneurial attitude to identify expedited clinical development pathways is a must
Ability to work effectively and independently to fast-moving timelines within a fast-paced working environment

***What the Head of Regulatory Affairs will get***

+ Competitive salary up to £150,000
+ excellent benefits
+ Work in a fantastic state-of-the-art facility
+ Lots of training and development opportunities

If this sounds like the perfect role for you, then please get in touch today!