SKILLS/COMPETENCIES REQUIRED

• Ability to work with changing priorities that involve multiple and concurrent projects.
• Strong analytical skills with the ability to assess scientific data.
• Excellent oral and written communication skills.
• Proficient computer skills, including relevant MS Office applications, Adobe Acrobat and eCTD submission software.
• Knowledge of GMP requirements and QA/QC procedures.
• Strong understanding of the Canadian Food and Drugs Act and of Canadian regulatory guidance documents and policies as well as ICH and international guidelines.
• Understanding of International Committee on Harmonization published guidelines
• Fundamental Understanding of the US Federal Food, Drug and Cosmetic Act and of FDA Guidance’s for Industry.
• Knowledge of Canadian Natural Health Product Regulations and applicable Provincial Regulations.

EDUCATION/EXPERIENCE

• Minimum B.Sc. in Chemistry, Pharmacy or Life Science
• Minimum 5 years experience in pharmaceutical regulatory affairs which includes filing and managing Canadian submissions.
  Note: This job description is intended to provide a general overview of the position. It is not an exhaustive list of all responsibilities, skills, or qualifications required for the role.
  Job Type: Full-time
  Pay: $90,000.00-$95,000.00 per year

Benefits:

• Dental care
• Extended health care
• Paid time off

Application question(s):

• Do you have an understanding of eCTD guidelines?

Education:

• Bachelor’s Degree (required)

Experience:

• pharmaceutical regulatory affairs: 5 years (preferred)
• Health Canada: 5 years (required)

Work Location: In perso

• Effectively manages assigned Regulatory Affairs Projects independently and when needed incorporates the assistance of other staff or consultants to ensure a successful conclusion to the project.
• Reviews, evaluates, prepares and files submission to Health Canada and the US FDA. Ensures that submissions meet format and content requirements as well as ensures the accuracy and completeness of statements, data and conclusions in reports and summaries for inclusion in Regulatory submissions.
• Builds and maintains a healthy working relationship with Regulatory Agencies. Uses the relationship to understand expectations beyond that which is presented in guidelines and policy statements.
• Organizes and facilitates meetings and teleconferences to maintain progress of projects. Tracks critical attributes of projects to ensure accountability and efficiency. Supports the generation of reports as required.
• Resolves any technical queries or deficiency letters relating to any submission in a timely manner within deadlines. Reviews, evaluates, prepares and files responses to Health Canada and FDA requests for clarification/letters of deficiency.
• Helps evaluate regulatory dossiers for new business opportunities.
• Provides mentorship to junior staff.
• Builds and maintains a healthy working relationship with business partners. Liaises with partners to collect documents and information for submission preparation or in response to technical queries/deficiency letters.
• Builds and maintains a good working relationship with Regulatory Agencies. Uses the relationship to understand expectations beyond that which is presented in guidelines and policy statements.
• Contributes to an efficient and effective regulatory affairs team.
• Provides regulatory counsel to ensure that all activities comply with regulations. Provides cross-functional input from an operational, scientific and technical viewpoint.
• Monitors regulatory maintenance of approved drug products. Maintains current awareness of regulatory guidelines (Health Canada, ICH, EMEA, FDA, etc.) and shares knowledge with the department. Reviews Change Controls and determine filing requirements.
• Reviews and approves product labelling to meet regulatory requirements. Reviews promotional material to ensure compliance to Health Canada regulations, PAAB guidelines and/or ASC guidelines (as applicable).
• Performs other regulatory affairs functions and activities as assigned to achieve departmental or operational priorities and prioritizes other responsibilities to meet additional work requirements.