Lead Industrial Placement Screening Coordinator Capability Green, Luton Permanent, Start ASAP £DOE + Flexible Benefits Experienced administrator, who's hit the ceiling in your current role...
My client, an expanding Biotech Organisation are currently seeking to recruit an Associate Director of Regulatory Affairs to join their Regulatory team. This position plays a key role in the clinical trial submission process. The role will be based from my client's offices in Cambridge.
My clients development activities are growing rapidly, and they are currently seeking a full-time Regulatory Affairs Associate Director to help drive our 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 other global markets.
- Provide regulatory affairs guidance and proactive, practical hands-on approach to achieve the required authorisations for local and international CTA's.
- Regulatory affairs activities with particular focus on regulatory compliance for clinical trials.
- Develop or establish working relationships with internal and external 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 my client to ensure appropriate standards are met
- To communicate progress and identify risks and issues arising on regulatory issues to the Vice President, Regulatory Affairs and the Development Clinical Trial Team.
- Contribute to a range of project teams, as required
- Manage 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 within Regulatory affairs.
- Expert level of knowledge in pre-approval 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.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Neal.Panting@SRG.co.uk or +441753 589626