Regulatory Affairs Associate
An exciting opportunity to join an international CRO that specialises in oncology and orphan diseases has emerged. ProClinical is seeking a Regulatory Affairs Associate on behalf of the company to join their head offices in Slough.
The Regulatory Affairs Associate will prepare and submit 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 also be responsible for supporting the department in clinical trial application maintenance.
- Participating with all departmental project related activities.
- Preparing and reviewing clinical trial application sot both Competent Authorities and Ethics Committees.
- Developing and maintain an understanding and familiarity with the current global Regulatory Affairs environment.
- Acting as a Regulatory Lead for small global clinical trials.
- Using appropriate IT and software tools to ensure the correct format and presentation of documents.
- Maintaining Trial Master Filing.
- Performing other duties as assigned by Regulatory Affairs & Technical Writing management.
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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