At a Glance
- Tasks: Lead regulatory compliance and communication for plasma operations in Canada.
- Company: Grifols, a global leader in healthcare since 1909.
- Benefits: Competitive salary, professional development, and impactful work in healthcare.
- Other info: Join an international team dedicated to improving lives through innovative healthcare solutions.
- Why this job: Make a difference in healthcare while advancing your career in a dynamic environment.
- Qualifications: 10+ years in regulatory affairs with strong leadership skills.
The predicted salary is between 121500 - 148500 $ per year.
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
The Regulatory Affairs Director is responsible for assisting with all aspects of regulatory compliance, communications, submissions and licenses. This role includes:
- Representing Canada Regulatory Affairs for Plasma Operations with agencies and associations, including PPTA.
- Serving as Authorized Official for Canadian Health Authorities.
- Ensuring that all processes comply with applicable national and international regulations, guidelines and legislation.
- Directing the operation of the Canadian Regulatory Affairs for Plasma Operations Department.
- Compiling and submitting regulatory documents according to regulatory requirements for source plasma collection.
- Communicating with local and international Health Authorities.
- Negotiating to secure prompt regulatory approvals.
- Preparing and/or reviewing responses to Health Authorities letters in a timely manner.
- Assisting in completing, maintaining and renewing site licenses (BELs), foreign site GMP licenses and medical laboratory licenses.
- Reviewing and assessing Change Controls, including classification of changes requiring authorization amendment.
- Maintaining an active knowledge of registration status and steering filings through the approval process.
- Establishing and maintaining positive working relationships internally and externally.
- Monitoring regulations, guidance documents, and manufacturing procedures for changes.
- Supporting periodic inspections performed by clients and the Health Authorities.
- Developing and leading compliant regulatory strategies supporting business objectives.
- Assuring training and professional development of staff.
- Providing regulatory training and advice internally.
REQUIRED SKILLS, QUALIFICATIONS AND EXPERIENCE:
- 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 national and international applicable regulations and standards.
- Proven ability to communicate and present effectively in English.
- Proficient in usage and handling of computers and related peripherals.
- Demonstrated analytical/problem solving abilities.
This position reports to: VP, Quality for Plasma Self-sufficiency Projects. Supervises: Departmental Supervisor for Regulatory Affairs Manager.
Director, Regulatory Affairs – Canada in Toronto employer: Grifols, S.A
Grifols is an exceptional employer that fosters a collaborative and innovative work culture, dedicated to improving healthcare globally. With a strong emphasis on employee growth, the company offers extensive training and development opportunities, ensuring that team members are well-equipped to excel in their roles. Located in Toronto, Ontario, employees benefit from a vibrant city atmosphere while contributing to meaningful projects that enhance the lives of millions.
