Senior Regulatory Executive
Hemel Hempstead, United Kingdom
- Key role for development projects and marketed products in oncology and neurology, providing direction globally in international multi-disciplinary teams.- Mentoring staff in developing regulatory strategies and directing execution to deliver the desired business outcome, while minimising resource demand and compliance risk.- Responsible for National, MR and Centralised processes, working closely both with consultants and agencies including IMB, MHRA, DKMA and EMA. - Led a successful IND filing and supported a further approved NDA filing in the USA