Senior Regulatory affairs Associate
Senior Regulatory Affairs Associate
6 month contract
Senior Regulatory Affairs Associate is required in a pharmaceutical company to support EU heads of Regulatory affairs with busy projects, allowing the leads to focus more on strategy.
* Executes regulatory activities for team members or projects in accordance with applicable regulations and guidelines under the supervision of the Regulatory Affairs Manager.
* Primary responsibility for compilation and release of submissions to regulatory agencies. Assists manager with regulatory strategy formulation through research, analysis and evaluation of alternative approaches
* Participates on project teams and provides guidance to clinical, nonclinical and CMC functions on a wide range of regulatory matters including document requirements, clinical trial conduct, regulatory submissions and maintenance.
* Preparation, organization and coordination of data / documents for submission to regulatory agencies.
* Handles routine responses to data and information requests from regulatory agencies with minimal oversight.
* Provides review of clinical trial documents (protocols, ICFs, etc)
* Assists with electronic compilation of regulatory submissions as required.
* Assists manager with formulation of regulatory strategy through research, analysis and evaluation of alternative approaches
* Provides interpretation to teams of new guidance documents or regulatory initiatives impacting the project under the direction of the manager.
* Clinical Development - basic understanding of the phases, processes and techniques used within a clinical development environment including protocol design and development.
* Good Clinical Practices (GCP) - understands good clinical practices and can apply to a research environment
* BS in a life science and 3 years direct regulatory experience. or
* MS/PharmD in a life science and 2 years direct regulatory experience.
To apply for the role please email firstname.lastname@example.org
Hydrogen UK Limited is acting as an Employment Business in relation to this vacancy.