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.

Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.

Regulatory Affairs Director is responsible for assisting with all aspects of regulatory compliance, communications, submissions and licenses. Representing Canada Regulatory Affairs for Plasma Operations with agencies and associations, including PPTA. Serve as Authorized Official for Canadian Health Authorities.

POSITION OBJECTIVE:

Ensuring that all processes comply with applicable national and international regulations, guidelines and legislation.

• Direct the operation of the Canadian Regulatory Affairs for Plasma Operations Department
• Compile and submit in a timely manner, regulatory documents according to regulatory requirements for source plasma collection.
• Communication with local and international Health Authorities. Support, communication and coordination (as necessary) with local Health Authorities. Negotiate to secure prompt regulatory approvals
• Prepare and/or review responses to Health Authorities letters in a timely manner (e.g. Notice of Non-Compliance, Notice of Deficiency and Clarifaxes)
• Assist in completing, maintaining and renewing site licenses (BELs), foreign site GMP licenses and medical laboratory licenses.
• Prepare annual report changes and list of donor suitability documents for submission to BRDD annually (does not include annual report for errors/ accidents).
• Review product labels.
• Review and assessment of Change Controls, including classification of changes requiring authorization amendment.
• Maintain an active knowledge of registration status and steer filings through the approval process.
• Establish and maintain positive working relationships internally and externally, to ensure timely registration of products/indications, line extensions and processes
• Maintain and support regulatory product compliance and consistently demonstrate commitment to compliance and quality requirements in daily job function.
• Monitor regulations, guidance documents, and manufacturing procedures, processes and practices for changes, and ensure that changes are communicated and that appropriate actions are taken to maintain compliance.
• Support periodic inspections performed by clients and the Health Authorities.
• Serve as Authorized Official for Canadian Health Authorities and as a point of contact for regulatory issues for other agencies (e.g., HC, State Departments of Health). Serve as Authorized Official for FDA
• Serve as representative for Canadian Regulatory Affairs for Plasma Operations for agencies and associations, including PPTA.
• 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, educate and train other employees to familiarize them with regulatory requirements.

NOTE: This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Other regulatory responsibilities may be assigned as needed.

REQUIRED SKILLS, QUALIFICATIONS AND EXPERIENCE:

1. Post-secondary education in Management, Pharmacy, Manufacturing or related fields.
2. At least 10 years of technical experience and/or regulatory experience in pharma or blood industry.
3. 5 or more years of supervisory and / or managerial experience.
4. Sound medical and scientific understanding of national and international applicable regulations and standards.
5. Proven ability to communicate and present effectively in English.
6. Proficient in usage and handling of computers and related peripherals.
7. Demonstrated analytical/problem solving abilities.

This position reports to: VP, Quality for Plasma Self-sufficiency Projects

Supervises: Departmental Supervisor for: Regulatory Affairs Manager

Location: Grifols HQ in Toronto

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