Senior Regulatory Affairs Associate
ProClinical is advertising an exciting opportunity to full-service, boutique CRO which offers specialist expertise and a full spectrum of drug development services. The company is seeking a Senior Regulatory Affairs Associate to join their head offices in Slough.
The Regulatory Affairs Associate will manage clinical trial applications of new and established pharmaceuticals performed at or by the company, ensuring that applications are conducted in accordance with the latest ICH and Regulatory Affairs guidelines. The incumbent will be responsible for ensuring that the client and senior management are kept fully informed of all aspects of the project.
- Participating with all departmental project related activities.
- Preparing and reviewing clinical trial applications to both Competent Authorities and Ethics Committees.
- Producing expert reports, investigator brochures, protocols and supporting regulatory documentation.
- Supporting regulatory affairs management in ensuring departmental awareness and compliance of current local, national, regional, and harmonised guidance and requirements for the format, content, and control of all types of regulatory and ethics procedures and submissions.
- Taking responsibility as the Regulatory Lead for designated complex global clinical trials.
- Using appropriate IT and software tools to ensure the correct format and presentation of documents.
- Maintaining the Trial Master Filing.
- Performing other duties as assigned by Regulatory Affairs and Technical Writing management.
- Developing and writing SOPs.
- Assisting in Business Development activities.
Skills and Requirements:
- At least a bachelor's degree, preferably in a health or life science related field.
- Demonstrable experience with CROs.
- Demonstrable experience with regulatory affairs.
- Strong team ethos, with a demonstrated track record of success in cross-functional team and fast moving environment.
- An ability to manage multiple simultaneously to ensure timely, on-target, and within budget accomplishment of tasks.
- Proficiency with Microsoft Office.
- Strong communication and presentation skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on + 44 203 078 9542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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