Regulatory Affairs Associate–Biologics Compliance (Hybrid)

Canadian Blood Services; Ottawa; Hybrid; CAD 86,000 - 102,000; Full time

Benefits offered by this job

Payment in lieu of vacation

Annual performance award up to 6%

Payment in lieu of benefits

Defined benefit pension plan

Employee discounts, wellness program,

Job summary

Canadian Blood Services is seeking a Temporary Full-time Regulatory Affairs Associate to join the Quality and Regulatory Affairs team in Ottawa. The role focuses on regulatory compliance for domestic and international biologics, with a hybrid work arrangement requiring 40% on-site presence.

You will support submissions, review regulatory filings, and help ensure governance and quality standards across blood products and services.

Qualifications

• Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology).
• Minimum of 2 years’ regulatory experience.
• Knowledge of domestic and international regulatory requirements, specific to fresh blood components, stem cells, tissues & organs.
• Thorough understanding of Good Manufacturing Practices.
• Demonstrated organizational, analytical, problem solving, time management and decision making skills.
• Ability to communicate effectively, verbally and in writing, with diverse audiences.

Responsibilities

• Assist in the development, implementation, and continuous improvement of the national Regulatory Submissions process.
• Develop, review, and evaluate regulatory filings for submission to regulatory authorities.
• Review change requests and customer letters submitted by the organization.
• Participate in reviews of industry regulations and standards.
• Provide interpretation of regulations and standards.
• Assist in definition, collection, analysis, and review of performance monitoring metrics.

Skills

Regulatory affairs

GMP knowledge

Regulatory submissions

Written communication

Cross-functional teamwork

Analytical skills

Time management

Documentation writing

Education

Bachelor’s degree in science

Job description

Canadian Blood Services is seeking a Temporary Full-time Regulatory Affairs Associate to join the Quality and Regulatory Affairs team in Ottawa. The role focuses on regulatory compliance for domestic and international biologics, with a hybrid work arrangement requiring 40% on-site presence.

You will support submissions, review regulatory filings, and help ensure governance and quality standards across blood products and services.