Regulatory Affairs Associate

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

Job posting ID: 9236

Employment status: Temporary full-time

Position's anticipated start date: 2026-10-19

Position's anticipated end date: 2028-04-18

Salary/Rate of pay: $86,400 - $101,700

Application deadline: 2026-09-30

This role requires a minimum of 40% on-site presence. Additional on-site work may be required based on business needs. On-site expectations are subject to change and may be adjusted on a temporary or permanent basis.

This external job posting may close earlier than the advertised deadline. We recommend applying as soon as possible.

About The Role

Canadian Blood Services is looking for a Temporary Full-time Regulatory Affairs Associate to join our dynamic Quality and Regulatory Affairs team.

The Quality and Regulatory Affairs division is responsible for providing daily support and subject-matter expertise to Canadian Blood Services in regulatory and quality matters, helping the organization to thrive as a biologics manufacturer and provider of transfusion and transplantation services.

In this role, you will integrate and apply your knowledge of domestic and international regulations governing all aspects of Canadian Blood Services’ biological products (fresh blood products, plasma protein products, stem cells, tissues and organs) and services.

Formula for success

• Leveraging your expertise in compliance management, you will, assist in the development, implementation, and continuous improvement of the national Regulatory Submissions process as it relates to submissions.
• Harnessing your proficiency in regulatory oversight, you will develop, review, and evaluate regulatory filings for submission to regulatory authorities.
• Drawing on your acumen in governance and compliance, you will participate in the review of change requests and customer letters submitted by the organization.
• Leveraging your understanding of industry protocols, you will participate in reviews of industry regulations and standards.
• Harnessing your mastery of statutory compliance, you will provide interpretation of regulations and standards.
• Drawing on your aptitude for regulatory navigation, you will assist in the definition, collection, analysis, and review of performance monitoring metrics.

Desired Education And Skills

• 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 are required.
• Ability to work on cross-functional teams and the ability to communicate effectively, verbally and in writing, with diverse audiences and personnel.
• Proficient in writing and editing technical documents.
• Respect for the sensitivity and confidentiality of documents received and reviewed.

What We Offer You

• Payment in lieu of vacation.
• Annual performance award up to 6%.
• Payment in lieu of benefits.
• Defined benefitpension plan.
• Employee discounts, wellness program, professional resources.

What You Can Expect

• This role will work in a hybrid environment with requirements to be onsite at Canadian Blood Services location 40% of the time.

Together, the work we do connects people and changes lives — including your own.

Be part of a dynamic, collaborative and caring organization committed to saving and improving lives. Thousands of patients depend on us every day for reliable access to safe blood, plasma, stem cells and organs and tissues.

We acknowledge that the work of Canadian Blood Services spans many Territories and Treaty areas across the country, and we are grateful for the Traditional Knowledge Keepers and Elders who have guided us in this important work. We recognize the land and waters that have inspired our work and offer gratitude to those Indigenous peoples on whose territory we work, live and play.

Diversity and inclusion play a vital role in ensuring health equity for patients across Canada. We are committed to reflecting Canada’s population in our organization and fostering an environment where all employees can be their authentic selves, with equal opportunities to succeed and contribute.

We thank all applicants for their interest. However, only those considered for an interview or those invited to participate in an assessment will be contacted. Emails are sent directly from our system, to ensure you receive them please add [e-mail] and [e-mail] to your safe senders list.

Applicants who require accommodation should discuss their needs with us.