Regulatory Affairs Associate

Please note this role will work in a hybrid environment. The successful candidate must be located near a Canadian Blood Services site and will be working a mixture of on-site and off-site work based on the parameters for our operations to meet the needs of our donors, our staff and our communities. Currently, employees are expected to have an in-person presence for at least 40% of their work time. This requirement may vary depending upon circumstances.

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Job category: Quality and regulatory affairs
Job posting ID: 5632

​Employment status: Regular full-time
Position's anticipated start date:  2024-07-02 

Classification: PTS/MGT/IT B
Salary/Rate of pay: $78,895 - $92,638

Application deadline: 2024-04-03 
Application requirements:

• Your up-to-date resume.
• We recommend you save a copy of the job posting for reference throughout the recruitment process.

Do you currently work for Canadian Blood Services? All employees must apply via the internal career page .

  Together, we can make all the difference in the lives of others.

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. 

If you are looking for a rewarding experience with a values and mission-driven team, join Canada’s Lifeline and make a meaningful difference.

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.

About the role
Canadian Blood Services is looking for a  Regular 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

• 4 weeks' vacation
• Annual performance award up to 6%
• Comprehensive group health, dental and vision benefits for you and your family
• 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 one of Canadian Blood Services location 40% of the time. 
• You will work Monday to Friday, 37.5 hours per week, 7.5 hours a day, additional hours may be required depending on project requirements. 
• Travel requirements - travel will be required to attend team meetings and project commitments. 

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.

Canadian Blood Services requires that all employees be fully vaccinated (COVID 19 vaccine doses as approved by Health Canada), subject to any medical or other human rights considerations. Persons who have been vaccinated outside of Canada must contact their local Public Health Unit in order to obtain a vaccine equivalency certificate.

If this role resonates with you, we encourage you to apply by providing your up-to-date resume. This could be your first step towards a meaningful and inspiring career. Come to work each day knowing that you save lives.  

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. Applicants who require accommodation should discuss their needs with us.