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Job #02525

About our client Our client is an innovative drug development company. The firm develops pain reliever and acne treatment formulas. It uses advanced drug delivery technologies to create novel molecule formulations, which can be commercialized and are currently marketed by the company. They currently have three late-stage drugs in their clinical expansion channel. Position Location Senior Manager of Regulatory Affairs Ontario Salary Highly competitive package, commensurate with experience Responsibilities 1) Plan and coordinate regulatory submissions necessary to support clinical trials 2) Communicate directly with regulatory agencies to facilitate reviewing of regulatory applications 3) Work closely with project teams to ensure that all activities are conducted in compliance with relevant laws, regulations and guidance 4) Lead cross-functional teams in coordinating regulatory submissions 5) Ensure submissions are complete and properly formatted 6) Comply with applicable regulatory requirements 7) Assist in worldwide regulatory submissions 8) Perform regulatory research to assist in formulating regulatory strategic decisions Requirements 1) 5 years of experience in a related field 2) Cardiovascular experience preferred 3) Experience in IND product support 4) Experience in several USA NDA submissions to the FDA