Regulatory Affairs Associate

About the role

Canadian Blood Services is looking for a Regular full-time Regulatory Affairs Associate to join our dynamic Regulatory Affairs team in our Quality and Regulatory Affairs division.

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. 

As a Regulatory Affairs Associate, you will help ensure that biological products and related services meet regulatory requirements throughout their lifecycle. Working closely with internal teams and regulatory authorities, you will contribute to regulatory submissions, compliance activities, inspections, process improvements, and reporting. This role is well suited to someone who enjoys interpreting complex regulations, building collaborative relationships, and finding practical solutions that support quality, compliance, and organizational goals.

Formula for success

• Using your knowledge of regulatory requirements, you will develop and support regulatory strategies that help products and services meet approval, compliance, and reporting obligations throughout their lifecycle.
• Drawing on your ability to interpret regulations and standards, you will provide clear guidance to internal stakeholders, helping teams make informed decisions and navigate complex regulatory expectations.
• You will prepare high-quality regulatory submissions, reports, and responses that are accurate, complete, and delivered on schedule, supporting successful interactions with regulatory authorities.
• Through strong collaboration and relationship-building skills, you will work effectively with cross-functional teams, suppliers, and regulatory agencies to address issues, and maintain compliance.
• Leveraging both your GMP experience and effective collaboration skills you will coordinate regulatory and non-regulatory inspections.
• Applying your analytical and problem-solving abilities, you will assess regulatory risks, investigate compliance concerns, and identify opportunities to strengthen processes and improve outcomes.
• By promoting consistent processes, delivering training, and monitoring performance metrics, you will help drive continuous improvement within regulatory submissions, reporting, and compliance activities. 

Desired education and skills

• Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology). Regulatory Affairs certification or postgraduate training is considered an asset, including professional certification (e.g., RAC) or postgraduate programs in Regulatory Affairs.
• A minimum of 2 years of experience in pharmaceutical, device or biologic manufacturing under Good Manufacturing Practices is required, which should include development/support, scientific affairs or operations.
• Preferred minimum of 2 years’ regulatory experience, with sound knowledge of domestic and international regulatory requirements, specific to fresh blood products, stem cells, tissues, and organs.
• Experience supporting regulatory submissions and audits, including preparing documentation, responding to findings, and implementing corrective actions within a regulated environment.
• Comprehensive knowledge of Canadian regulatory requirements pertaining to the collection of blood and the manufacturing of blood components, cells, tissues and organs is required.
• Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents.
• Knowledge of regulatory agency structures, processes and key personnel.
• Ability to properly interpret and apply international regulatory requirements, guidelines, policies and regulations.

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 Canadian Blood Services Operational site location 40% of the time/2 days of the week.
• Depending on where you are located, you may be expected to travel several times per year, and as required.