Specialist, US Regulatory Affairs Job in Hamilton, Ontario Canada

Purpose of Job:The Specialist, Regulatory Affairs has responsibility for managing strategic regulatory operations and providing expert advice on the guidelines and regulations to clients within the US Regulatory environments.Major Responsibilities1.Assists in the development of strategic regulatory plans for client drug development programs.2.Plans and prepares or assists in the preparation of all submission types (e.g. CTA, IND, NDA, BLA, Annual Reports, expedited safety reports, etc) in adherence with applicable Acts, Regulations and Guidance for submission to government agencies (focus on FDA).3.Facilitates Read more […]

July 1, 2011 • Tags: , , • Posted in: General • Comments Off on Specialist, US Regulatory Affairs Job in Hamilton, Ontario Canada