Head of Regulatory Affairs - Aberdeen, United Kingdom - TauRx Pharmaceuticals Ltd

Description

TauRx are seeking to recruit a Head of Regulatory Affairs to join the team.


Role Purpose:

The Head of Regulatory Affairs will define and implement the company's regulatory strategy,
maintaining excellent relationships with competent authorities while advocating the company's
position.
The role will be responsible for coordinating the writing and review of submissions to competent
authorities, overseeing and directing submissions through the approval process, and presenting
regulatory affairs to external stakeholders.
In addition, the role will monitor and assess national and international regulations and their impact in
the company, as well as assisting in designing, contracting and the management of clinical trials from
a regulatory perspective.


Education:

Appropriate undergraduate degree
PhD an advantage


Experience:

Minimum 10 years' experience in the pharmaceutical/biotech industry within regulatory affairs
Overseen the regulatory approval of therapeutic drugs from submission through the entire
process, in either Europe or the US, preferably both
Established relationships with regulators
Multi-discipline drug development, preferably within a BioTech
Senior management experience in a small or medium company environment
This is a full-time position, ideally based in our Aberdeen office, however remote working may
also be considered.
A full job description is available from the People and Culture Department.
Applications should me be made in writing by forwarding a covering letter and CV to