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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive regulatory compliance expertise in the pharma and blood industry, with a strong focus on managing submissions, licenses, and communications with health authorities. Proven leadership in developing regulatory strategies and ensuring adherence to national and international regulations.
Highest-signal resume keywords
Regulatory ComplianceRegulatory Affairs ManagementHealth Authority CommunicationGMP LicensingRegulatory Strategy Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Document CompilationChange Control AssessmentRegulatory SubmissionsQuality Compliance MonitoringAnalytical Problem-Solving
Soft Skills
Effective CommunicationNegotiation SkillsTeam Leadership
Tools & Technologies
Computer Proficiency
Industry Keywords
Pharma IndustryBlood IndustryPPTACanadian Health AuthoritiesFDAGMPPlasmapheresis Centers
About the role
Key responsibilities & impact- Assist with all aspects of regulatory compliance, communications, submissions and licenses
- Represent Canada Regulatory Affairs for Plasma Operations with agencies and associations, including PPTA
- Serve as Authorized Official for Canadian Health Authorities and FDA
- Ensure processes comply with applicable national and international regulations, guidelines and legislation
- Direct the Canadian Regulatory Affairs for Plasma Operations Department
- Compile and submit regulatory documents for source plasma collection
- Communicate and coordinate with local and international Health Authorities
- Negotiate to secure prompt regulatory approvals
- Prepare and/or review responses to Health Authorities letters
- Complete, maintain and renew site, foreign site GMP, and medical laboratory licenses
- Prepare annual report changes and donor suitability document lists for BRDD submission
- Review product labels and assess Change Controls
- Maintain registration status and steer filings through approval
- Maintain regulatory product compliance and quality requirements
- Monitor regulatory and manufacturing changes and ensure appropriate actions are taken
- Support client and Health Authority inspections
- Develop and lead compliant regulatory strategies supporting business objectives, including establishing or acquiring plasmapheresis centers
- Assure training and professional development of staff; provide regulatory training and advice internally
- Report to the VP, Quality for Plasma Self-sufficiency Projects and supervise the Regulatory Affairs Manager
Requirements
What you’ll need- Post-secondary education in Management, Pharmacy, Manufacturing or related fields
- At least 10 years of technical experience and/or regulatory experience in pharma or blood industry
- 5 or more years of supervisory and/or managerial experience
- Sound medical and scientific understanding of applicable national and international regulations and standards
- Proven ability to communicate and present effectively in English
- Proficient in using and handling computers and related peripherals
- Demonstrated analytical/problem-solving abilities
Benefits
Comp & perks- International team working to improve healthcare
- Professional development and training opportunities for staff