Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.  Job #02498 About our client Our client is a biotechnology company focused on developing new treatments for under-served markets in oncology and infectious diseases. Position Location Regulatory Affairs Specialist Montreal, Quebec Salary Highly competitive package, commensurate with experience Responsibilities 1) Prepare regulatory submissions and regulatory documents 2) Assemble non-clinical, CMC, and clinical sections of regulatory submissions 3) Assist in the preparation of annual updates, regulatory meetings, teleconferences, and Advisory Committee meetings 4) File and capture (electronic) regulatory documentation 5) Keep abreast of regulatory submission procedures and changes Requirements 1) M. Sc. (a plus) 2) 3 – 5 years of industry experience 3) 2+ years of experience in regulatory affairs 4) Knowledge of US, Canadian and European regulations a plus 5) Track record of managing multiple projects parallelly 6) Ability to prepare multiple regulatory submissions simultaneously 7) Proficiency in computers (i.e. Word, Excel, and PowerPoint) 8) Good communication and interpersonal skills 9) Good technical writing skills in the areas of non-clinical, CMC, and clinical development 10) Languages skills – fluency in English and French (written and verbal)
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