Sr. Regulatory Affairs Associate

Artech Information Systems • Mississauga, Ontario, Canada • 6h ago

Key Responsibilities:

Responsible for managing a small product portfolio with guidance from more senior regulatory professionals.
Participate in regulatory team meetings and present project status updates and provide tactical approaches to addressing issues of moderately complex programs/projects.
Help track and identify impact of changes in regulatory legislation and competitor information for assigned product(s) or projects.
Act as a knowledgeable resource to other Regulatory Affairs personnel within the department.
Use and update regulatory information systems for planning, preparing, tracking, and storing submissions to regulatory agencies.
May initiate or contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.
Perform document filing and retrieval functions as directed, or in conjunction with departmental SOPs.
Relevant regulatory experience in the prescription pharmaceutical industry with experience in clinical submissions. Degree in a scientific field is required.
Post-graduate certification in Regulatory Affairs is considered an asset.
Understanding and knowledge of the fundamentals of Canadian regulatory legislation and guidances.
Excellent planning and organizational skills and the ability to work simultaneously on several projects with tight timelines.
Must be able to facilitate effective interactions within the Regulatory Affairs Canada Department, as well as with other departments and sites within the Company (for example, Clinical Research and Global Patient Safety).

Email:

Artech Information Systems

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