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• Aylesbury
• Posted 26th Jul 2010
• Posted by: ProClinical
• Salary: GBP per annum
• Job Type: Permanent
• Reference: 2611980
• This job has been viewed 54 times since it was posted.

Job Description

Job Title: Senior Regulatory Affairs Analyst, Surrey Company: An exciting opportunity to join one of the biggest European pharmaceutical companies has become available for Senior Regulatory Affairs French Speaking Analyst The Senior Regulatory Affairs Analyst will be reporting to the European Medical Director and will be responsible for the following duties: # The review, preparation, submission and follow-up of regulatory submission of clinical trials to the French Health Regulatory Agency. #Maintaining the preparations for supervisions, variations, clinical trials, renewals and Marketing Authorisation. # Maintaining the marketing and clinical authorisation applications, marketing authorisation for primary submissions. # Maintaining and understanding the process for changing the legal status of a product and providing the support dossiers. # Comfortable in discussing microbiology, toxicology, and quality assurance. Qualifications: Only candidates with bachelor\'s level degree in life sciences, ideally with a post-graduate qualification and having relevant clinical research experience will be considered. The ideal candidate will be/have these attributes: #THE CANDIDATE MUST BE ABLE TO SPEAK FRENCH#Knowledge of devices and CE Marking is crucial.#Maintaining compliant regulatory information and an ability to successfully prioritise work on multiple tasks. #Computer proficient with exceptional attention to detail. #Excellent knowledge of EU guidelines and French regulations (EMEA & FHPSA). #Effective written communication and management skills. #Proven experience within regulatory affairs is required. Additional/How to Apply: For more information or to apply, please contact Michael on or send your CV to