An exciting global leader in the biopharmaceutical industry is searching for a Director to join their team due to their success in Phase III clinical trials. Reporting directly into the CEO, you will have the chance to strategically support and mentor up to 6 direct reports and oversee the regulatory structure from top to bottom.
Their products cover 4 key therapeutic areas including oncology, neurology, inflammatory diseases and viral diseases, which are at clinical trials in 15 countries and have recently successfully had FDA approval.
This is the perfect opportunity for an aspiring Director, or an experienced Director who is ready to take a lateral step into an innovative product pipeline!
Responsibilities
- Drafting dossiers and regulatory responses for health authorities
- Presenting ideas to optimise regulatory processes
- Support the QMS by participating in the life cycle procedure of a product
- Be an involved player in the continual improvement of human and animal research
Requirements
- Post-graduate qualification preferred
- 7+ years' experience in Regulatory Affairs, with previous leadership or project management experience
- Experience in writing and submitting dossiers and clinical study documents
- Experience in medical writing
Please reach out with your CV directly or apply now!