Calian Group
Length of contract: 1-year
Division: Pharma CRO
Do YOU want to join one of Canada’s fastest-growing Contract Research Organizations (CRO) that is dedicated to providing quality and service excellence to our pharmaceutical and biotechnology clients and their customers?
At Calian CRO, we continually strive to expand our knowledge base and experience by hiring talented people to further our remarkable growth. Our aim is to find the right people for the right roles to deliver services in line with industry best practices.
Calian CRO is looking for a Regulatory Affairs Associate on behalf of our client for a limited 1-year contract. The role will be primarily remote, with occasional attendance in the Montreal office for meetings.
Do you have a passion for day-to-day regulatory activities? If so, we would love to hear from YOU!
Position Overview
The regulatory affairs associate will support the preparation, submission and defense of well-presented drug submissions and communications to FDA, Health Canada, and other regulatory agencies in order to ensure regulatory compliance of product dossiers and sponsor operations.
Responsibilities
- Prepare dossiers for regulatory submissions for pipeline (CTA), pre-market (NDS) and marketed (SNDS, NC, etc.) products, ensuring timely submission to and authorization from FDA, Health Canada, and other regulatory agencies with optimal approval conditions and labelling.
- Prepare development/registration strategies in conjunction with the DRA manager/Director and global regulatory, clinical teams.
- Plan and co-ordinate meetings with FDA and Health Canada.
- Provide regulatory support and advice to internal customers to ensure all relevant functional and business needs/challenges are appropriately addressed from the regulatory/compliance standpoint.
- Ensure compliance of electronic systems, files and reports to facilitate management and compliance with regulatory submissions, activities and records.
- Ensure compliance of company products and activities with the Food and Drug Act, and Regulations, as well as existing and emerging Health Canada guidelines, policies and requirements; and industry association codes (E.g. labelling, advertising, promotions).
- Fulfill other duties as required.
Qualifications
- Degree in Science (BSc or equivalent)
- Minimum 3years of experience in regulatory affairs.
- Fluent in English and French (written or oral).
- Knowledgeable of regulatory processes in Canada.
- Excellent written and verbal communication.
- Excellent organizational, problem solving and interpersonal skills.
- Knowledge of Microsoft Office, excel, power point, Internet.
- Ability to work in an ever-changing environment and changing priorities.
- Must be able to work in an environment that involves multiple and concurrent projects.
- Flexible, team player, positive attitude and willingness to always learn more.
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