Global Regulatory Affairs Director
Amy Lloyd is recruiting for a Global Regulatory Affairs Director to join a highly innovative Biotechnology Company focused in the development of novel therapeutic antibodies on a permanent basis based at their HQ in Cambridgeshire.
The main purpose of the role, reporting in to the VP of Regulatory Affairs, will be to provide strategic regulatory affairs leadership to drive the rapid development of new therapeutic antibodies initially in inflammation and immuno-oncology across the EU, US and Taiwan.
Key responsibilities will include:
Provide strategic regulatory affairs guidance for the development of new drug candidates 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 relationships with regulatory authorities; industry community and partners in industry as appropriate to programmes and business plans
To identify, select and 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 Vice President, Regulatory Affairs and/or the Development Project Team as appropriate
Contribute to a range of project teams, as required
Contribute to organising and scheduling teamwork to ensure that projects meet agreed regulatory procedural deadlines
Education & Experience:
Bachelor of Science (BSc) with a second degree preferred
Significant industry/biotech experience of early-phase clinical trialsSkills & Knowledge:
Expert level of knowledge in regulatory affairs
Knowledge of Development Good Practices (GxP)
Exceptional communication, collaboration, influencing and leadership 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 Amy Lloyd on 01438 842979 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
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 47164 in all correspondence.