Overview
Scientific & Regulatory Affairs Associate Jobs in Winnipeg, Manitoba, Canada at Medicure
Summary:
***This position is 100% in office at our location in Winnipeg, Manitoba***
The Scientific and Regulatory Affairs Associate’s function is to use their scientific training and writing to support manufacturing and product development activities, including clinical trial activities, through the preparation and review of protocols and reports, deviations, change controls and provide decision-making based on scientific rationale. Also to ensure the timely preparation and review of regulatory submissions and promotional materials in accordance with relevant RA procedures.
Responsibilities:
- Reviewing, preparation and editing scientific or manufacturing protocols, analyses & reports, deviations and change controls 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)
- Review and submit promotional materials to applicable regulatory agencies prior to dissemination, according to Company SOPs, including labelling updates.
- Support Medicure’s clinical trial activities.
- 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
- Review information and provide input into development of new pharmaceutical products.
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.
- Regulatory experience (FDA or Health Canada) preferred.
- Experience working with deadlines.
- 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.
- Work is in office Monday to Friday 8 am to 5 pm
- Applicants must be Canadian citizens or have permanent residency.
Title: Scientific & Regulatory Affairs Associate
Company: Medicure
Location: Winnipeg, Manitoba, Canada