Regulatory Affairs Associate

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 benefit pension 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.