Posted 23 days ago
Director, Regulatory Affairs (Canada)
@ GRIFOLS, S.A.
Alberta
Overview
Grifols, a global healthcare company, is hiring a Director, Regulatory Affairs (Canada) at its Toronto headquarters on a hybrid schedule. The role directs Canadian regulatory affairs for plasma operations, manages submissions and communications with health authorities, and serves as Authorized Official for Canadian Health Authorities. Salary is not yet disclosed.
Responsibilities:
- Diriger le département des affaires réglementaires pour les opérations de plasma
- Préparer et soumettre les documents réglementaires aux autorités de santé
- Communiquer avec les autorités de santé locales et internationales
- Surveiller les règlements et gérer les changements de conformité
- Former et conseiller le personnel sur les exigences réglementaires
Requirements summary:
- Formation postsecondaire en gestion, pharmacie, fabrication ou domaine connexe
- Au moins 10 ans d'expérience technique ou réglementaire dans l'industrie pharmaceutique ou sanguine
- 5 ans ou plus d'expérience de supervision ou de gestion
- Compréhension scientifique et médicale des règlements nationaux et internationaux
- Excellente communication en anglais
Tools & skills
Source and dates
Employer career site / ATS feed · successfactors
- Employer posting date
- 2026-10-16
- First seen by our source
- 2026-10-09
- Source record updated
- 2026-10-24
These dates describe the source record, not a live verification that the employer is still hiring. Check the original posting.
Job details
| Seniority | Director |
| Department | Physicians & advanced practice |
| Experience | 10+ years |
| Management experience | 5+ years |
| Manages people | Yes |
| Work setting | Office |
| Position | Mostly sitting |
| Physical demands | physical low · computer high |
| Languages | English, French |
| Education | Bachelor’s degree (required) |
| Fields of study | Management, Pharmacy, Manufacturing |
Summary and details written by AI from the posting; the employer’s posting is the authority.
GRIFOLS, S.A.
Saved company profile
Historical company information from a saved The Jobs API profile (LinkedIn/Crunchbase fields). It is not live-verified; figures may have changed. Missing values remain unknown.
Innovating for patients and society
Full company description
Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people all over the world. A leader in essential plasma-derived medicines and transfusion medicine, we develop, produce and provide innovative healthcare services and solutions in more than 110 countries. Patient needs and our ever-growing knowledge of many chronic, rare and prevalent diseases, sometimes life-threatening, drive our innovation in plasma-based therapies and other biopharmaceuticals to enhance quality of life. Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology and infectious diseases. With a workforce of over 23,000 employees in more than 30 countries and regions, we are committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership in the industry. Our work has a positive social and economic impact in the countries where we operate, creating jobs and generating wealth. People are at the heart of what we do, and we strive to create an inclusive, diverse, fair and equal society. Maintaining and promoting a workforce that reflects this reality leads to enhanced professional relationships and helps us to give our best to patients, donors and customers. In 2024, Grifols was named one of TIME’s ‘World’s Best Companies’ for the second year in a row, reaffirming our commitment to excellence. We were also recognized by Forbes as one of the "Best Employers for Women 2023," reflecting our dedication to fostering an inclusive and supportive workplace for all. To maintain a positive community and overall respectful communication, please keep our community guidelines in mind.
- LinkedIn followers
- 286,595
- People associated on LinkedIn
- 13,691
- Reported office locations
- Parc Empresarial Can Sant Joan, Av. de la Generalitat, 152-158, Sant Cugat del Vallès, Barcelona 08174, ES
- Carrer de Palou, 6, Parets del Valles, Catalonia 08150, ES
- Business categories
- Health Diagnostics
- Health Care
- Biopharma
- Clinical Trials
- Biotechnology
- Life Science
- Medical
- Manufacturing
- Pharmaceutical
- Other recorded names
- Grifols Egypt for Plasma Derivatives
- GRIFOLS, S.A.
- Grifols
- Specialties
- Plasmapheresis
- Plasma derived therapies
- Diagnostics
- Intravenous therapies
- Clinical nutrition
- Automate drug compounding
- Drug inventory control
- and Healthcare
- Profile identifies a recruitment agency
- No
- Reported total investment
- 0
Currency and observation date were not supplied; this is not a current valuation or a funding round.
Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people all over the world. A leader in essential plasma-derived medicines and transfusion medicine, we develop, produce and provide innovative healthcare services and solutions in more than 110 countries. Patient needs and our ever-growing knowledge of many chronic, rare and prevalent diseases…
| Field | Value |
|---|---|
| Industry | Pharmaceutical Manufacturing |
| Company size | 10,001+ employees |
| Headquarters | Sant Cugat del Vallès, Barcelona |
| Organization type | Public Company |
| Year founded | 1909 |
| Specialties | PlasmapheresisPlasma derived therapiesDiagnosticsIntravenous therapiesClinical nutritionAutomate drug compounding Drug inventory controland Healthcare |
| Open jobs on Jobsy | 33 |
| View page |
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. |
This role is based out of our corporate office in Toronto. It follows a hybrid work schedule, with 3 days per week in the office and 2 days per week working remotely.
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:
- 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.
The salary range for this position is currently being assessed and will be disclosed upon completion of the compensation review process, in accordance with applicable transparency requirements.
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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Location: NORTH AMERICA : Canada : ON-Toronto:CAHOME - Home Address Canada
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