Regulatory Affairs Associate

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

Benefits offered by this job

4 weeks' vacation

Annual performance award up to 6%

Health, dental and vision benefits for

Employee discounts, wellness program

Job summary

Canadian Blood Services is seeking a Regular full-time Regulatory Affairs Associate to join our Regulatory Affairs team in our Quality and Regulatory Affairs division. This role focuses on ensuring biological products meet regulatory requirements throughout their lifecycle, collaborating with internal teams and regulators, and preparing submissions, inspections, and continuous improvement.

Hybrid work with 40% on-site presence at our operations site and travel as needed.

Qualifications

• Bachelor’s degree in science; RAC or regulatory certification is an asset.
• At least 2 years of experience in pharmaceutical, device or biologic manufacturing under GMP.
• Regulatory experience with domestic and international requirements for blood products, stem cells, tissues and organs preferred.
• Experience supporting regulatory submissions and audits; capable of corrective actions within a regulated environment.
• Knowledge of Canadian regulatory requirements for blood collection and manufacturing of blood components.
• Ability to interpret and apply international regulatory requirements, guidelines and policies.

Responsibilities

• Develop regulatory strategies to meet approval, compliance, and reporting obligations throughout product lifecycle.
• Provide clear guidance to internal teams on regulatory expectations.
• Prepare high-quality regulatory submissions, reports, and responses delivered on schedule.
• Collaborate with cross-functional teams, suppliers, and agencies to address issues and maintain compliance.
• Coordinate regulatory and non-regulatory inspections.
• Assess regulatory risks, investigate compliance concerns, and identify process improvements.
• Promote standardized processes, deliver training, and monitor performance metrics.

Skills

Regulatory knowledge

Regulatory submissions

Analytical skills

Cross-functional collaboration

Education

Bachelor's degree in science

Regulatory certification (asset)

Job description

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.

Job posting ID: 9219

Employment status: Regular full-time
Salary/Rate of pay:$86,400 - $101,700

Application requirements

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

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.

About the role

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

TheQuality and Regulatory Affairsdivision 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.

• 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.
• 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.

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.