Director, Regulatory Affairs (Canada)

Job summary

The Director of Regulatory Affairs is responsible for overseeing all regulatory compliance, submissions, and licensing for Plasma Operations in Canada. They serve as the Authorized Official for Canadian Health Authorities and lead regulatory strategies to ensure business objectives are met.

Job details

The Director of Regulatory Affairs is responsible for overseeing all regulatory compliance, submissions, and licensing for Plasma Operations in Canada. They serve as the Authorized Official for Canadian Health Authorities and lead regulatory strategies to ensure business objectives are met. Candidates must have at least 10 years of technical or regulatory experience in the pharmaceutical or blood industry, with at least 5 years in a supervisory role. A post-secondary education in Management, Pharmacy, Manufacturing, or a related field is required.

What you’ll do

The Director of Regulatory Affairs is responsible for overseeing all regulatory compliance, submissions, and licensing for Plasma Operations in Canada. They serve as the Authorized Official for Canadian Health Authorities and lead regulatory strategies to ensure business objectives are met.

Requirements

Candidates must have at least 10 years of technical or regulatory experience in the pharmaceutical or blood industry, with at least 5 years in a supervisory role. A post-secondary education in Management, Pharmacy, Manufacturing, or a related field is required.

Listed skills

• Problem solving · Preferred
• Quality assurance · Preferred
• Regulatory Compliance · Preferred
• Staff Development · Preferred
• Team Leadership · Preferred
• Project management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Regulatory compliance
• Regulatory submissions
• Health authority communication
• Quality assurance
• Change control
• GMP compliance
• Product labeling
• Strategic planning
• Team leadership
• Analytical skills
• Problem solving
• Regulatory strategy
• Staff development
• Technical writing
• Project management

Job areas

• Healthcare
• Management & Leadership
• Science & Research
• Manufacturing
• Legal

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