Quality & Regulatory Affairs Associate

Found in: Jooble CA O C2 - 2 weeks ago

Winnipeg MB, Canada Bioscience Association Manitoba Full time

Scientific and Regulatory Affairs Associate
The Scientific and Regulatory Affairs Associate’s function is to use their scientific training to support manufacturing and product development activities through the preparation and review of protocols and reports, and provide decision-making based on scientific rationale. Also to ensure the timely preparation and review of regulatory submission within pre-defined schedules in accordance with relevant RA procedures, tools, and templates and coordinate the final submissions to regulatory authorities. Contact with regulatory agencies or third parties (e.g., CRO’s) and ensure relevant departments are informed of regulatory authority communications.
Reviewing, preparation and editing scientific or manufacturing protocols, analyses & reports, based on scientific rationale and guidance documents, for Medicure’s commercially approved products and for those in development.
· Troubleshooting of manufacturing, quality or development issues using scientific rationale.
· Participate in and support the regulatory affairs process.
· Assist in coordinating, organizing, and preparing regulatory submissions to ensure compliance with the applicable regulations and guidelines (eg. Coordinate the submission of advertising materials to the appropriate regulatory agencies prior to dissemination, according to Company SOPs, including labelling updates.
· S. regulatory guidelines and policy.
· Assist in the interpretation and decisions based on regulatory guidelines and policies, by preparing risk assessments as required.
· Participate in tracking regulatory project status.
· Keep an up-to-date file of regulatory documents (both paper and electronic).
· Participate in and support the quality assurance process, through document preparation and review (eg change controls and quality agreements).
· Some travel may be required for manufacturing facility visits or for regulatory meetings, although infrequent.
Bachelor’s degree in a scientific discipline (e.g. Experience with FDA regulatory submissions preferred.
· Proficiency with Microsoft Office applications and document formatting.
· Travel would be minimal but must have a valid passport.
· Applicants must be Canadian citizens or have permanent residency.
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