Scientific and Regulatory Affairs Associate

7 days ago

Winnipeg, Canada Bioscience Association Manitoba Full time
Scientific and Regulatory Affairs Associate

Location: Winnipeg, Manitoba

Reports to: President & C.O.O.

Summary:

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.

Responsibilities:

· 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. post approval supplements, IND annual reports, post marketing annual reports, NDA filings)

· Coordinate the submission of advertising materials to the appropriate regulatory agencies prior to dissemination, according to Company SOPs, including labelling updates.

· Read and remain updated with U.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).

· Assist in the preparation and drafting of SOPs.

· Review information and provide input into development of new pharmaceutical products.

· Some travel may be required for manufacturing facility visits or for regulatory meetings, although infrequent.

Qualifications:

· Bachelor’s degree in a scientific discipline (e.g. Chemistry, Pharmacy or Life Sciences) or equivalent, however Ph.D. preferred.

· Demonstrated abilities in critical thinking, and preparation of convincing written arguments is critical.

· GMP manufacturing experience preferred.

· Ability to prioritize workload to ensure deadlines and timelines are met.

· Experience working with deadlines and understanding of the FDA approval regulations and process preferred.

· Experience with FDA regulatory submissions preferred.

· Exceptional verbal and written communication.

· Able to work independently and in a team environment with a diverse group of people.

· Must have a high level of attention to detail.

· Proficiency with Microsoft Office applications and document formatting.

· Applicants living in Winnipeg or surrounding area will be given preference.

· Able to travel outside of Canada (primarily the U.S.). Travel would be minimal but must have a valid passport.

· Applicants must be Canadian citizens or have permanent residency.

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