Director, Regulatory Development
CK Group are recruiting for a Director, Regulatory Development to join a small pharmaceutical company based remotely anywhere in the UK with occasional travel to their head office in Oxfordshire on a permanent basis.
The Role: To be responsible for all Regulatory aspects of this company. To develop and implement Regulatory strategies from study design through to product commercialisation. You will be the sole contact for Regulatory so must be able to work independently.
- To develop and implement regulatory strategies from study design through to product commercialisation.
- To lead the process in the development of regulatory submission, including but not limited to; MAA's, Orphan and PIP applications, Accelerated, Prime and Conditional approvals.
- Oversight of regulatory activities that are outsourced to a Regulatory Service Provider.
- To pro-actively identify new regulatory trends and challenges and predict the effect of changes on regulations, policies and procedures.
- To conduct due diligence and develop risk management recommendations.
- To lead interactions with Health Authorities (MHRA/EMA/FDA).
- At least a University degree in a scientific discipline. Ideally apost-graduate degree.
- Extensive experience in regulatory affairs gained in pharmaceutical companies.
- Experience independently developing and implementing regulatory strategies for clinical trials.
- Strong vendor management experience.
- Proven record of leading interactions with Health Authorities (MHRA/EMA/FDA).
- Ability to manage organizational change.
- Neurological, mental health or rare disease experience preferred.
Apply: Entitlement to work in the UK is essential. For more information or to apply for this position, please contact Andy Leake by phone on 01438 842 966 or email on firstname.lastname@example.org. Please quote reference 49625 in all correspondence.