The posting
The Lead Consultant-Regulatory role focuses on maximizing and protecting the commercial interests of our clients. Our consultants often work closely with marketing, quality assurance, project management and legal teams, so that filing of submissions are undertaken in a timely manner.
In this contract role, you will be reporting to the Manager, Regulatory Services. You will drive the registration and maintenance of client’s facility licences (Drug Establishment Licence (DEL), NHP Site Licence (SL) and Medical Device Establishment Licences (MDEL)) according to applicable regulations. Responsible for obtaining and maintaining GMP Certificates, CoPPs from Health Canada and other related activities. The role specifically prioritizes, plans and organizes regulatory-related projects to ensure smooth implementations. The role may involve coordinating the work of several consultants. This is a full-time temporary maternity leave coverage role for a period of 6 months with a possibility of extension.
Knowledge and experience in the following are required:
- Establishing project plans that capture all aspects of the scope of work
- Prioritizing and managing regulatory team projects
- Completing critical assessments of data and documents to identify gaps against regulatory requirements
- Developing and maintaining excellent working relations with Health Canada, Provincial Regulatory Bodies as well as Industry Association taskforces
- Demonstrate a deep understanding of technical requirements to comply with Health Canada Regulations pertaining to DEL, MDEL and SL
- You will also be required to maintain up-to-date knowledge of regional and national regulations, guidelines, and advisory documents, along with advances in relevant scientific fields.
- Obtain GMP Certificates and CoPPs from Health Canada, get them Notarized, Authenticated and Notarized as necessary
- Prepare, review and submit DEL, MDEL, SL applications, amendments, updates, notifications, renewals to Health Canada in a timely manner
- Evaluate and assess impact to the DEL, MDEL, SL in line with product lifecycle changes
- Respond to Health Canada deficiency notices and IRNs within the specified time frame
- Ensure completeness, accuracy and acceptability of GMP evidence documents, forms, etc. when submitting DEL, MDEL, SL related submissions to Health Canada
- Manage API Table-A efficiently while tracking all changes and maintain a comprehensive Table-A
- Manage NERBY tracker for foreign sites listed on a DEL foreign building annex
- Support Health Canada GMP audits for DEL, MDEL, Site Licence queries
- Keep updated with Health Canada changes pertaining to all Establishment Licenses - DEL, MDEL and Site Licence
- Proactively manage risks by assessing supply chain changes and help prevent any pause in the importation and distribution of healthcare products
- Liaise with global suppliers, clients, internal Quality team, Health Canada and ensure effective communication to facilitate timely submission approvals
- Knowledge and experience with review of Drug and NHP testing requirements in Canada in line with Food and Drug Regulations and NHP Regulations
Salary range: CAD 70,000 – 80,000 annually
Annual salary will be based on candidate’s experience, skill, knowledge, and qualifications relevant to the role.
This posting is for an existing vacancy.
Requirements
A minimum of a Bachelor of Science degree is required, along with 3-5 years of relevant industry experience in this area of facility license management.
Benefits
If you're a Regulatory professional in the pharmaceutical industry, we have the environment and exposure to the type of work you want to do.
Q&C welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.
