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Principal Consultant
2 weeks ago
Jim Gleeson is recruiting for a Non-Clinical Principal Consultant to join a successful and growing consultancy providing support to biotech and pharmaceutical company clients throughout the entire drug development process.
**Responsibilities**:
As Clinical Principal Consultant you provide strategic, technical and regulatory advice/services to clients in the area of non-clinical development of human medicinal products, across a wide range of therapeutic indications.
**Key duties will include**:
- Provide innovative drug development plans, data gap analyses and international regulatory strategies from a Clinical perspective for complex products within the changing regulatory environment
- Provide innovative drug development plans, data gap analyses and international regulatory strategies from a Non-Clinical perspective for complex products within the changing regulatory environment
- Educate clients on current regulatory trends and expectations. Where relevant champion the client's view for development of products with other contractors such as CROs
- Maintain oversight of project budgets and ensure delivery of project goals within agreed client/team timelines
- Representing clients in regulatory agency interactions and providing regulatory solutions to agency objections
**Qualifications**:
As Non-Clinical Principal Consultant you will require:
- A relevant PhD or MSc
- Extensive industry based non-clinical development experience spanning a range of therapeutic areas, ideally spanning Europe and the US
- Ideally be a European Registered Toxicologist and have RAC or TOPRA accreditation
- Experience of negotiation with a range of national regulatory authorities
- Proven ability in defining and delivering creative scientifically driven solutions to technical development and regulatory issues
- Ideally have direct experience to providing strategic regulatory planning for the delivery of industry development goals, up to marketing authorisation
- Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the UK or internationally
**Benefits**:
Salary of £90.000 - £110.000 plus an excellent benefits package.
**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53767 in all correspondence.
