Associate Director, Global Regulatory Affairs
Sam Whyley-Smith is recruiting for an Associate Director Regulatory Affairs to join a Global Biotechnology Company based in Cambridge on a permanent basis.
The main purpose of the role will be: Reporting to the VP Regulatory Affairs, you will help drive clients rapid development of new therapeutic antibodies initially in inflammation and immuno-oncology. This role will provide exposure to regulatory affairs including in the US, EU and Taiwan.
- Provide regulatory affairs guidance and proactive, practical hands-on input to achieve the required authorisations for national and multi-national clinical trials
- Regulatory affairs activities with particular focus on regulatory compliance for clinical trials
- Develop or establish working relationships with third party partners in industry as appropriate to clinical research programmes and business plans
- To liaise with external contractors related to regulatory compliant work carried out on behalf of the company and ensure appropriate standards are met
- To communicate progress and identify risks and issues arising on regulatory issues to the VP, Regulatory Affairs and the Development Clinical Trial Team
- Contribute to a range of project teams, as required
- Contribute to organising and scheduling teamwork to ensure that projects meet agreed regulatory procedural deadlines
- Bachelor of Science (BSc) with a second degree preferred
- Significant industry/biotech experience of early-phase clinical trials
- Expert level of knowledge in pre-authorisation regulatory affairs
- Knowledge of Development Good Practices (GxP)
- Exceptional communication, collaboration and influencing skills
- Maintain a high standard of professionalism when representing the Company, both internally and externally
- Excellent personal integrity, energy and drive
For more information or to apply for this position, please contact Sam Whyley-Smith on 01246 5800 40 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46285 in all correspondence.