Hybrid Regulatory Affairs Associate: Compliance

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

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.