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About the Role
Canadian Blood Services is seeking a Regulatory Affairs Associate to join their Quality and Regulatory Affairs division. This role supports the organization in regulatory and quality matters, ensuring biological products and services meet regulatory requirements throughout their lifecycle. The position involves regulatory submissions, compliance, inspections, process improvements, and reporting, suitable for someone who enjoys interpreting regulations, building relationships, and finding practical solutions.
Responsibilities
- Develop and support regulatory strategies to meet product and service approval, compliance, and reporting obligations.
- Provide clear guidance to internal stakeholders on regulations and standards.
- Prepare high-quality regulatory submissions, reports, and responses.
- Collaborate with cross-functional teams, suppliers, and regulatory agencies to address issues and maintain compliance.
- Coordinate regulatory and non-regulatory inspections.
- Assess regulatory risks, investigate compliance concerns, and identify process improvement opportunities.
- Drive continuous improvement in regulatory submissions, reporting, and compliance activities through process promotion, training, and performance monitoring.
Requirements
- Minimum of 2 years of experience in pharmaceutical, device, or biologic manufacturing under Good Manufacturing Practices (GMP), including development/support, scientific affairs, or operations.
- Preferred minimum of 2 years of regulatory experience with knowledge of domestic and international regulatory requirements for fresh blood products, stem cells, tissues, and organs.
- Experience supporting regulatory submissions and audits, including documentation preparation, response to findings, and corrective action implementation.
- Comprehensive knowledge of Canadian regulatory requirements for blood collection and manufacturing of blood components, cells, tissues, and organs.
- Knowledge of regulatory history, guidelines, policies, standards, practices, requirements, and precedents.
- Knowledge of regulatory agency structures, processes, and key personnel.
- Ability to interpret and apply international regulatory requirements, guidelines, policies, and regulations.
Skills
- Regulatory Affairs
- Good Manufacturing Practices (GMP)
- Regulatory Submissions
- Compliance
- Audits
- Risk Assessment
- Problem-Solving
- Collaboration
- Relationship-Building
- Process Improvement
Location
- Onsite (40% presence required)
Work Type
- Hybrid
- Regular full-time
Experience Level
- Minimum 2 years of experience in manufacturing under GMP
- Preferred minimum 2 years of regulatory experience
Education Level
- Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology)
- Regulatory Affairs certification or postgraduate training is an asset (e.g., RAC, postgraduate programs in Regulatory Affairs)
Salary/Compensations
- $86,400 - $101,700
Benefits
- 4 weeks' vacation
- Annual performance award up to 6%
- Comprehensive group health, dental and vision benefits
- Defined benefit pension plan
- Employee discounts
- Wellness program
- Professional resources
About the Company
- Canadian Blood Services is a dynamic, collaborative, and caring organization committed to saving and improving lives by providing reliable access to safe blood, plasma, stem cells, and organs and tissues.
- The work of Canadian Blood Services spans many Territories and Treaty areas across the country.
- The organization is committed to reflecting Canada’s population and fostering an environment where all employees can be their authentic selves.
Equal Opportunity
- 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.
- Applicants who require accommodation should discuss their needs with us.