38 Medical Affairs jobs in Canada
Director, Medical Affairs
Posted today
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Salary:
Director, Medical Affairs
Kye Pharmaceuticals Inc. is a Canadian pharmaceutical company committed to bringing value to Canadians with medicines that fulfill clinically significant unmet needs. Our experienced team offers expertise in the Canadian pharmaceutical landscape from registration through to commercialization. Recognizing our employees are among our greatest assets, Kye is committed to developing and advancing our teams careers within the company.
The Director, Medical Affairs, will join a rapidly growing organization and lead the medical affairs function. You will be the subject matter expert on all products in Canada and hold the primary responsibility for providing clinical guidance over the life cycle of the brands. As part of this role, the Director, Medical Affairs is also expected to manage a team of Medical Science Liaisons (MSLs), with a portion of their time working remotely with colleagues and customers.
Reporting to the Vice President of Scientific Affairs, you will lead the medical affairs team to support the corporate objectives by developing and executing the medical strategy in Canada.
Responsibilities:
- Leads the development of strategic plans to support the medical objectives of the commercial team
- Leads MSL-linked activity and provides medical guidance to the commercial team.
- Provide medical input to product label proposals and optimization discussions.
- Provide medical input and review to clinical modules as needed for regulatory dossiers for submission to Health Canada and support during the review and negotiation process with Health Canada as applicable.
- Develops and delivers product training for head office and/or sales representatives, as needed
- Represents KYE as the medical and scientific field-based expert for all products by maintaining knowledge of relevant diseases, treatments, and the
- Leads the development of strategic plans to support the medical objectives of the commercial team
- Leads MSL-linked activity and provides medical guidance to the commercial team.
- Provide medical input to product label proposals and optimization discussions.
- Provide medical input and review to clinical modules as needed for regulatory dossiers for submission to Health Canada and support during the review and negotiation process with Health Canada as applicable.
- Develops and delivers product training for head office and/or sales representatives, as needed
- Represents Kye as the medical and scientific field-based expert for all products by maintaining knowledge of relevant diseases, treatments, and the competitive landscape to engage in high quality and respected scientific dialogue
- Represents Kye to medical professional groups, societies, and/or patient groups, as needed
- Represents Kye at national and/or international scientific meetings, as needed.
- Establishes rapport and strong working relationships with KOLs to support company objectives, as needed
- Plans, supports and/or executes specialized scientific/educational programs, as needed
- Plans, supports and/or conducts Advisory Boards and/or Consult Meetings as needed
- Presents scientific and clinical data internally and externally, as needed
- Evaluates proposals and coordinates Investigator Initiated Studies on a case-by-case where appropriate
- Provides medical input to promotional material review
- Provides medical input and or oversight to medical information queries
- Contributes clinical perspective and therapeutic area knowledge in all business development assessments
Qualifications:
- Advanced scientific degree preferred (i.e. MD, PharmD, PhD) with 3+ years of experience as an MSL or Medical Affairs leader in the pharmaceutical industry
- Ability to understand, interpret, and communicate (both written and verbally) clinical and scientific data across multiple therapeutic areas. French is considered an asset.
- Ability to think strategically and work collaboratively to develop and execute plans that will lead to the achievement of company objectives
- Ability to perform and excel in a dynamic environment
- Ability to motivate and inspire others both internally and externally by developing trusted partnerships with all stakeholders of the medical affairs team
- Ability to work cross-functionally
- Ability to speak publicly as a subject matter expert with proven presentation skills
- Valid Drivers Licence and ability to travel are requirements for this role
- Prior experience in Medical Information and/or Compliance would be an asset
Role is expected to be hybrid (remote/office) and Kyes offices are currently located at 5200 Yonge Street, Toronto
Orthopaedic Surgeon - Medical Affairs
Posted 330 days ago
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Position: Orthopaedic Surgeon
Unit: Medical Affairs
St. Thomas Elgin General Hospital
The Department of Surgery at St. Thomas Elgin General Hospital (STEGH) is seeking three Orthopaedic Surgeons for its growing orthopedic program in St. Thomas. STEGH offers a variety of surgical services to meet the changing needs of the community, including orthopedics, general surgery, urology, ophthalmology, otolaryngology, dental and oral maxillofacial. Last year, STEGH conducted more than 9,200 surgical procedures and endoscopies, and is positioned for continued growth.
Applicants must be certified with the Royal College of Physicians and Surgeons of Canada or equivalent and be eligible for licensure with the College of Physicians and Surgeons of Ontario. Special assistance in obtaining a license through the CPSO can be provided for those with US, UK or equivalent credentials.
Candidates must possess a community orthopaedic skill set that includes, but is not limited to, primary total hip and knee arthroplasty and basic community orthopaedic trauma.
The successful applicant will join the team at STEGH, with access to Operating Room time and space in the Ambulatory Care/Fracture Clinic, collaborating with our experienced orthopaedic surgeons. The candidate must participate in orthopaedic on-call coverage at STEGH. Letters of reference are required as part of the application process.
Why St. Thomas Elgin General Hospital?
STEGH is renowned for its culture of compassion, respect, and spirit of innovation with the primary goal of delivering high quality care. In 2022, STEGH was honoured locally as Employer of the Year and was named one of the World’s Best Hospitals according to Newsweek.
Nestled just 25 km south of London, St. Thomas is a hidden gem in the heart of southwestern Ontario. With the recent opening of the Amazon Fulfillment Facility and the Volkswagen Battery Cell Factory under construction, Elgin County is poised for significant growth, with its population projected to increase by 25-40% by 2046.
Elgin County, along with London-Middlesex, is at the forefront of sustainable supportive housing initiatives, enhancing the quality of life for its residents. As a small city strategically positioned between larger urban areas, St. Thomas presents impressive housing potential that is attracting both homebuyers and investors. The city boasts picturesque landscapes, a rich history, and a vibrant community spirit, offering a perfect blend of small-town warmth and modern amenities.
Additionally, its close proximity to scenic Port Stanley means easy access to beautiful beaches, charming shops, and vibrant community events.
Anatomic/General Pathologist - Medical Affairs
Posted today
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Job Description
Position: Anatomic/General Pathologist
Unit: Medical Affairs
St. Thomas Elgin General Hospital
The Department of Pathology at St. Thomas Elgin General Hospital (STEGH) is seeking a talented and dynamic pathologist to join our esteemed team of two pathologists. Located in St. Thomas, Ontario, STEGH is a fully accredited 179-bed facility renowned for its comprehensive medical services and state-of-the-art facilities.
About Us:
- Cutting-edge Facility: Our brand-new laboratory services department sets the standard for laboratory workflow and testing quality with the latest technology.
- Integrated Support: We partner with the Department of Pathology and Laboratory Medicine (PaLM) at London Health Sciences Centre (LHSC). This partnership guarantees Laboratory support for all staff, and consultation services in both the clinical laboratory area and in pathology.
- Diverse Case Load: Our pathology department handles approximately 7,500 specimens annually, focusing on areas such as Gastrointestinal, Gynecological, Breast, Urological, and Dermatopathology, along with Clinical Autopsy services.
- Academic Affiliation: As an affiliate of Western University's pathology residency program and pathologist’s assistant program, we offer opportunities for teaching and professional growth. Pathologists at STEGH are eligible for Adjunct Professor status at Western University.
- Location: Conveniently situated just 30 minutes from downtown London and Western University, and only 15 minutes from the scenic beaches of Port Stanley, STEGH offers a vibrant work environment in the heart of Southwestern Ontario. With the recent opening of the Amazon Fulfillment Facility and the Volkswagen Battery Cell Factory under construction, Elgin County is poised for significant growth, with its population projected to increase by 25-40% by 2046.
Position Requirements:
- Certification: Candidates must be certified in Anatomic or General Pathology by the Royal College of Physicians and Surgeons of Canada.
- Licensure: Licensed by the College of Physicians and Surgeons of Ontario for independent practice.
Benefits: - Continuing Education: We support our team's professional development with remuneration for continued medical education, fostering a culture of excellence in patient care.
Why Join Us?
This is an exciting opportunity to work in a collaborative and innovative environment, making a significant impact on patient care while enjoying the benefits of a supportive community and a diverse clinical caseload.
STEGH is celebrated for fostering a culture rooted in compassion, respect, and continuous innovation, all aimed at providing exceptional care. This commitment to excellence was recently acknowledged in May 2025 when STEGH received the prestigious Business Achievement Award from the London Chamber of Commerce in the category of "Excellence in People and Culture," standing out among numerous distinguished nominees.
If you are a dedicated pathologist seeking to advance your career in a progressive healthcare setting, apply today and become part of our dedicated team at St. Thomas Elgin General Hospital.
Anatomic/General Pathologist - Medical Affairs
Posted 18 days ago
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Job Description
Position: Anatomic/General Pathologist
Unit: Medical Affairs
St. Thomas Elgin General Hospital
The Department of Pathology at St. Thomas Elgin General Hospital (STEGH) is seeking a talented and dynamic pathologist to join our esteemed team of two pathologists. Located in St. Thomas, Ontario, STEGH is a fully accredited 179-bed facility renowned for its comprehensive medical services and state-of-the-art facilities.
About Us:
- Cutting-edge Facility: Our brand-new laboratory services department sets the standard for laboratory workflow and testing quality with the latest technology.
- Integrated Support: We partner with the Department of Pathology and Laboratory Medicine (PaLM) at London Health Sciences Centre (LHSC). This partnership guarantees Laboratory support for all staff, and consultation services in both the clinical laboratory area and in pathology.
- Diverse Case Load: Our pathology department handles approximately 7,500 specimens annually, focusing on areas such as Gastrointestinal, Gynecological, Breast, Urological, and Dermatopathology, along with Clinical Autopsy services.
- Academic Affiliation: As an affiliate of Western University's pathology residency program and pathologist’s assistant program, we offer opportunities for teaching and professional growth. Pathologists at STEGH are eligible for Adjunct Professor status at Western University. li>Location: Conveniently situated just 30 minutes from downtown London and Western University, and only 15 minutes from the scenic beaches of Port Stanley, STEGH offers a vibrant work environment in the heart of Southwestern Ontario. With the recent opening of the Amazon Fulfillment Facility and the Volkswagen Battery Cell Factory under construction, Elgin County is poised for significant growth, with its population projected to increase by 25-40% by 2046.
Position Requirements:
- Certification: Candidates must be certified in Anatomic or General Pathology by the Royal College of Physicians and Surgeons of Canada.
- Licensure: Licensed by the College of Physicians and Surgeons of Ontario for independent practice.
Benefits: - Continuing Education: We support our team's professional development with remuneration for continued medical education, fostering a culture of excellence in patient care.
Why Join Us?
This is an exciting opportunity to work in a collaborative and innovative environment, making a significant impact on patient care while enjoying the benefits of a supportive community and a diverse clinical caseload.
STEGH is celebrated for fostering a culture rooted in compassion, respect, and continuous innovation, all aimed at providing exceptional care. This commitment to excellence was recently acknowledged in May 2025 when STEGH received the prestigious Business Achievement Award from the London Chamber of Commerce in the category of "Excellence in People and Culture," standing out among numerous distinguished nominees.
If you are a dedicated pathologist seeking to advance your career in a progressive healthcare setting, apply today and become part of our dedicated team at St. Thomas Elgin General Hospital.
Quality Assurance & Regulatory Affairs Associate - Pharmaceuticals & Medical Devices
Posted today
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Job Description
Quality Assurance & Regulatory Affairs Associate Position –
Pharmaceuticals & Medical Devices
Our company is a specialty medical device, cell-tissue-organs, and pharmaceutical importer and distributor. We are committed to providing exceptional service and brand awareness to thousands of hospitals, dental and oral surgery clinics that we serve in Canada, the United States and around the world. Our company represents leading brands in their respective categories.
We are importer and distributor of drugs including: narcotics, prescriptions, ethical and OTC drugs, medical devices (MD), cell-tissue-organs (CTO) and natural health products (NHP) in Canada. Our company is also an importer and distributor of medical devices (MD), and human-cell-tissue products (HCTP) in the USA. Furthermore, our company is the owner of a health Canada drug license for dental anesthetics.
The QA & RA associate position is a GMP role responsible for a wide variety of Quality Assurance and Regulatory Affairs activities related to Drugs, MDs, CTOs and NHPs. In addition, the QA & RA Associate will communicate with vendors, prepare documentation and processes, contribute to drugs or MD submissions, and maintain all documentation and records.
Compensation: 60K to 70K
Location: Mississauga, ON
Essential Job Functions and Responsibilities
General
- Support and maintain a process that ensures all requirements from Health Canada and FDA are met
- Maintain all documentation and necessary records for Drugs, MDs, CTOs and NHPs activity
Quality Assurance
- As approved AQPIC, perform all the duties related to narcotics activity onsite (e.g. product receiving, inspection, distribution, monthly reporting etc.)
- Maintain the Quality Management Systems (QMS) for drugs, MDs, CTOs , and HCTPs
- Write new SOPs. Review and update of SOPs and standard forms.
- Documentation review and drug inspection for batch release, including narcotics
- Full process for Quality Product Complaints for drugs, MDs, CTOs, and NHPs
- Review and documentation of all returned products
- Review and documentation of starting materials, and emergency kits
- Review of imported NHP finished products
- Participate in Health Canada GMP inspection
- Participate in Health Canada, and FDA inspections for MDs, and CTOs /HCTPs
- Participate in annual self-inspection and corrective /preventive actions
- Support on ISO-13485 certification and recertification for MD Quality Management System
- Documentation of change controls and deviations
- Prepare, review and maintain all documentation from DIN manufacturers
- Preparation, review and maintenance of any logs, spreadsheet, or records
- Support with staff GMP and QMS training
- Perform quality inspection of facilities
Regulatory Affairs
- Review and document all ADRs, and forward to respective authorities, when needed
- Support and records on drug pharmaco-vigilance process, and MD problem reporting
- Support on renewing all drug and MD licenses, and updating all licenses: DEL, MDEL, CTO, NHP SL, wholesale/ distributor, tissue bank, and FDA registrations
- Participate to comply with recall procedure for drugs, MDs in Canada, and MDs and HCTPs in USA
- Participate in Health Canada pharmaco-vigilance inspection
- Support submission process for existing and new products, drugs, MDs, and NHPs
- Support any regulatory change submission for drugs in eCTD format /software
- Support and review final submission documents, keep submission copies, and e-file
- Support international regulatory documentation requests
- Maintain and submit monthly narcotics report to Health Canada
Requirements
- Bachelor’s degree in science or a related field (e.g., Biology, Chemistry, Biochemistry, Biotechnology, Kinesiology, Pharmacology, Pharmacy, Biomedical Sciences, etc.)
- 4+ years of experience in pharmaceuticals and/or medical devices (MD) in an associate or above role
- Meet all Health Canada requirements to be approved as AQPIC (Narcotics activity)
- Skilled on writing GMP technical documents
- Experience on regulatory of drugs and MDs
- Strong knowledge of Health Canada (HC) Drug regulations, as well as HC and US FDA MD regulations.
- Specialized degree in Quality Assurance/ Regulatory Affairs and/ or Regulatory Affairs Certification (RAC) is considered an asset
- Able to be on-site for a minimum of 4 days a week
- Strong knowledge of Health Canada requirements for Good Manufacturing Practices (GMP) for drugs
- Strong knowledge of Health Canada requirements for Quality Management Systems (QMS) for MDs
- Experience in narcotics handling (e.g., AQPIC) is an asset
- Knowledgeable in FDA requirements for Quality Management Systems for MDs and HCTPs
- Experience in preparation of drug submission is an asset
- Knowledgeable, thru education and /or professional experience in Drugs Pharmacovigilance and MDs Problem Reporting
- SAP experience is an asset
- Knowledge and experience in Health Canada requirements for NHPs activities preferred
- Excellent writing and communication skills
- Strong computer knowledge, including MS office (Word, Excel), Adobe, and network environments
- Self-management and organizational skills
- Strong problem-solving skills
What's in it for you
- Salary range $60,000 - $0,000
- Bonuses 1,500 to 2,000 annually based on performance
- Full benefits package
- RRSP plan
- 15 PTO days to start
Quality Assurance & Regulatory Affairs Associate – Pharmaceuticals & Medical Devices
Posted today
Job Viewed
Job Description
Quality Assurance & Regulatory Affairs Associate Position –
Pharmaceuticals & Medical Devices
Our company is a specialty medical device, cell-tissue-organs, and pharmaceutical importer and distributor. We are committed to providing exceptional service and brand awareness to thousands of hospitals, dental and oral surgery clinics that we serve in Canada, the United States and around the world. Our company represents leading brands in their respective categories.
p>We are importer and distributor of drugs including: narcotics, prescriptions, ethical and OTC drugs, medical devices (MD), cell-tissue-organs (CTO) and natural health products (NHP) in Canada. Our company is also an importer and distributor of medical devices (MD), and human-cell-tissue products (HCTP) in the USA. Furthermore, our company is the owner of a health Canada drug license for dental anesthetics. p>The QA & RA associate position is a GMP role responsible for a wide variety of Quality Assurance and Regulatory Affairs activities related to Drugs, MDs, CTOs and NHPs. In addition, the QA & RA Associate will communicate with vendors, prepare documentation and processes, contribute to drugs or MD submissions, and maintain all documentation and records.Compensation: 60K to 70K
Location: Mississauga, ON
Essential Job Functions and Responsibilities
General
- Support and maintain a process that ensures all requirements from Health Canada and FDA are met
- Maintain all documentation and necessary records for Drugs, MDs, CTOs and NHPs activity
Quality Assurance
- As approved AQPIC, perform all the duties related to narcotics activity onsite (e.g. product receiving, inspection, distribution, monthly reporting etc.)
- Maintain the Quality Management Systems (QMS) for drugs, MDs, CTOs , and HCTPs
- Write new SOPs. Review and update of SOPs and standard forms.
- Documentation review and drug inspection for batch release, including narcotics
- Full process for Quality Product Complaints for drugs, MDs, CTOs, and NHPs
- Review and documentation of all returned products
- Review and documentation of starting materials, and emergency kits
- Review of imported NHP finished products
- Participate in Health Canada GMP inspection
- Participate in Health Canada, and FDA inspections for MDs, and CTOs /HCTPs
- Participate in annual self-inspection and corrective /preventive actions
- Support on ISO-13485 certification and recertification for MD Quality Management System
- Documentation of change controls and deviations
- Prepare, review and maintain all documentation from DIN manufacturers
- Preparation, review and maintenance of any logs, spreadsheet, or records
- Support with staff GMP and QMS training
- Perform quality inspection of facilities
Regulatory Affairs
- Review and document all ADRs, and forward to respective authorities, when needed
- Support and records on drug pharmaco-vigilance process, and MD problem reporting
- Support on renewing all drug and MD licenses, and updating all licenses: DEL, MDEL, CTO, NHP SL, wholesale/ distributor, tissue bank, and FDA registrations
- Participate to comply with recall procedure for drugs, MDs in Canada, and MDs and HCTPs in USA
- Participate in Health Canada pharmaco-vigilance inspection
- Support submission process for existing and new products, drugs, MDs, and NHPs
- Support any regulatory change submission for drugs in eCTD format /software
- Support and review final submission documents, keep submission copies, and e-file
- Support international regulatory documentation requests
- Maintain and submit monthly narcotics report to Health Canada
Requirements
- Bachelor’s degree in science or a related field (e.g., Biology, Chemistry, Biochemistry, Biotechnology, Kinesiology, Pharmacology, Pharmacy, Biomedical Sciences, etc.) < i>4+ years of experience in pharmaceuticals and/or medical devices (MD) in an associate or above role
- Meet all Health Canada requirements to be approved as AQPIC (Narcotics activity)
- Skilled on writing GMP technical documents
- Experience on regulatory of drugs and MDs
- Strong knowledge of Health Canada (HC) Drug regulations, as well as HC and US FDA MD regulations.
- Specialized degree in Quality Assurance/ Regulatory Affairs and/ or Regulatory Affairs Certification (RAC) is considered an asset
- Able to be on-site for a minimum of 4 days a week
- Strong knowledge of Health Canada requirements for Good Manufacturing Practices (GMP) for drugs
- Strong knowledge of Health Canada requirements for Quality Management Systems (QMS) for MDs
- Experience in narcotics handling (e.g., AQPIC) is an asset
- Knowledgeable in FDA requirements for Quality Management Systems for MDs and HCTPs
- Experience in preparation of drug submission is an asset
- Knowledgeable, thru education and /or professional experience in Drugs Pharmacovigilance and MDs Problem Reporting
- SAP experience is an asset
- Knowledge and experience in Health Canada requirements for NHPs activities preferred
- Excellent writing and communication skills
- Strong computer knowledge, including MS office (Word, Excel), Adobe, and network environments
- Self-management and organizational skills
- Strong problem-solving skills
What's in it for you
- Salary range $60,000 - $0,000
- Bonuses 1,500 to 2,000 annually based on performance
- Full benefits package
- RRSP plan
- 15 PTO days to start
Quality Assurance & Regulatory Affairs Associate position - Pharmaceuticals & Medical Devic
Posted today
Job Viewed
Job Description
Job Description
Quality Assurance & Regulatory Affairs Associate position –
Pharmaceuticals & Medical Devices
HANSAmed is a specialty Medical Device, Cell-Tissue-Organs, and pharmaceutical importer and distributor. We are committed to providing exceptional service and brand awareness to thousands of hospitals, dental and oral surgery clinics that we serve in Canada, the United States and around the world. HANSAmed represents leading brands in their respective categories.
Hansamed Ltd /Citagenix is importer and distributor of Drugs including Narcotics, Prescription, ethical and OTC drugs, Medical Devices (MD), Cell-Tissue-Organs (CTO) and Natural Health Products (NHP) in Canada. Also, Hansamed Ltd /Citagenix is importer and distributor of Medical Devices (MD), and Human-Cell-Tissue products (HCTP) in USA. Furthermore, Hansamed Ltd is owner of Health Canada drug license for dental anesthetics. QA & RA associate position is a GMP role responsible for a wide variety of Quality Assurance and Regulatory Affairs activities related to Drugs, MDs, CTOs and NHPs. In addition, QA & RA associate will communicate with vendors, prepare documentation and processes, contribute to Drugs or MD submissions, and maintain all documentation and records. Detailed responsibilities are below.
Compensation: 60K to 70K
Location: Mississauga, ON.
Essential Job Functions and Responsibilities
General
- Support and maintain a process that ensures all requirements from Health Canada and FDA are met
- Maintain all documentation and necessary records for Drugs, MDs, CTOs and NHPs activity
- Ability to adapt and maintain attention to detail while working in a dynamic, fast-paced environment
Quality Assurance
- As approved AQPIC, perform all the duties related to Narcotics activity onsite (e.g. Product receiving, inspection, distribution, monthly reporting etc.)
- Maintain the Quality Management Systems (QMS) for Drugs, MDs, CTOs /HCTPs
- Write new SOPs. Review and update of SOPs and standard forms.
- Documentation review and drug inspection for batch release, including narcotics
- Full process for Quality Product Complaints for Drugs, MDs, CTOs, NHPs
- Review and documentation of all returned products
- Review and documentation of starting materials, and Emergency Kits
- Review of imported NHP finished products
- Participate in Health Canada GMP inspection
- Participate in Health Canada, and FDA inspections for MDs, and CTOs /HCTPs
- Participate in annual self-inspection and corrective /preventive actions
- Support on ISO-13485 certification and recertification for MD Quality Management System
- Documentation of Change controls and Deviations
- Prepare, review and maintain all documentation from DIN manufacturers
- Preparation, review and maintenance of any logs, spreadsheet, or records
- Support with staff GMP and QMS training
- Perform quality inspection of facilities
- Other responsibilities as related to Quality Assurance activities
Regulatory Affairs
- Review and document all ADRs, and forward to respective authorities, when needed
- Support and records on Drug PharmacoVigilance process, and MD Problem Reporting
- Support on renewing all drug and MD licenses, and updating all licenses: DEL, MDEL, CTO, NHP SL, wholesale/ distributor, tissue bank, FDA registrations
- Participate to comply with Recall procedure for drugs, MDs in Canada, and MDs and HCTPs in USA
- Participate in Health Canada PharmacoVigilance inspection
- Support submission process for existing and new products, drugs, MDs, NHPs
- Support any regulatory change submission for drugs in eCTD format /software
- Support and review final submission documents, keep submission copy and e-file
- Support international regulatory documentation requests
- Maintain, submit monthly narcotics report to Health Canada
- Other responsibilities as related to Regulatory Affairs activities
Requirements
Pre-Requisite for this position :
Bachelor’s degree in science or a related field (e.g., Biology, Chemistry, Biochemistry, Biotechnology, Kinesiology, Pharmacology, Pharmacy, Biomedical Sciences, etc.)
4+ years of experience in pharmaceuticals and/or Medical Devices (MD) in an associate or above role; meet all Health Canada requirements to be approved as AQPIC (Narcotics activity); skilled on writing GMP technical documents; proven experience on regulatory of drugs and MDs; strong knowledge of Health Canada (HC) Drug regulations, as well as HC and US FDA MD regulations.
Do not apply if you do not meet these minimum requirements.
Note : Specialized degree in Quality Assurance/ Regulatory Affairs and/ or Regulatory Affairs Certification (RAC) is considered an asset
- Strong knowledge, thru education and /or professional experience in QA systems and /or Regulatory Affairs for Drugs and Medical Devices
- 4+ years of experience in pharmaceutical and/or MD companies
- Ability to be present on-site for a minimum of 4 days/ week
- Strong knowledge of Health Canada requirements for Good Manufacturing Practices (GMP) for Drugs
- Strong knowledge of Health Canada requirements for Quality Management Systems (QMS) for MDs
- Experience in narcotics handling (e.g., AQPIC) is an asset
- Knowledgeable in FDA requirements for Quality Management Systems for MDs and HCTPs
- Experience in preparation of drug submission is an asset
- Knowledgeable, thru education and /or professional experience in Drugs Pharmacovigilance and MDs Problem Reporting
- SAP experience is an asset
- Knowledge and experience in Health Canada requirements for NHPs activities preferred
- Excellent writing and communication skills in English
- Very good computer knowledge, MS office (Word, Excel), Adobe, Network environment
- Strong Self-management skills and Organizational skills
- Strong problem-solving skills
What's in it for you
- Salary range $60,000 to $0,000 depending on experience
- Bonuses 1,500 to 2,000 annually based on performance
- Full benefits
- RRSP plan
- 15 PTO days to start
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