Sun Life compliance director overseeing CIRO trade supervision and risk - based monitoring across mutual fund and securities businesses. Leading regulatory oversight, transformation, reporting, and a high - performing compliance team.
About the role
- Regulatory Affairs Lead managing DEL, MDEL, and Site Licence submissions for pharmaceutical clients in Canada. Coordinating Health Canada approvals, GMP certificates, audits, and regulatory projects.
Responsibilities
- Maximize and protect the commercial interests of clients
- Work closely with marketing, quality assurance, project management, and legal teams to ensure timely submission filings
- Report to the Manager, Regulatory Services
- Drive registration and maintenance of client facility licences, including Drug Establishment Licences (DEL), NHP Site Licences (SL), and Medical Device Establishment Licences (MDEL)
- Obtain and maintain GMP Certificates and CoPPs from Health Canada
- Prioritize, plan, and organize regulatory projects for smooth implementation
- Coordinate the work of several consultants as needed
- Prepare, review, and submit DEL, MDEL, and SL applications, amendments, updates, notifications, and renewals
- Respond to Health Canada deficiency notices and IRNs
- Manage API Table-A and NERBY tracker
- Support Health Canada GMP audits and licence-related queries
- Assess supply-chain changes and proactively manage risks to prevent pauses in product importation and distribution
- Liaise with global suppliers, clients, internal Quality team, and Health Canada to facilitate timely submission approvals
Requirements
- A minimum of a Bachelor of Science degree is required
- 3-5 years of relevant industry experience in facility license management
- Knowledge and experience establishing project plans that capture all aspects of the scope of work
- Experience prioritizing and managing regulatory team projects
- Experience completing critical assessments of data and documents to identify gaps against regulatory requirements
- Excellent working relations with Health Canada, Provincial Regulatory Bodies, and Industry Association taskforces
- Deep understanding of technical requirements for Health Canada Regulations pertaining to DEL, MDEL, and SL
- Up-to-date knowledge of regional and national regulations, guidelines, advisory documents, and relevant scientific advances
- Ability to obtain GMP Certificates and CoPPs from Health Canada and complete notarization/authentication as necessary
- Experience preparing, reviewing, and submitting DEL, MDEL, and SL applications, amendments, updates, notifications, and renewals to Health Canada
- Ability to evaluate the impact of DEL, MDEL, and SL changes in line with product lifecycle changes
- Ability to respond to Health Canada deficiency notices and IRNs within specified time frames
- Ability to ensure completeness, accuracy, and acceptability of GMP evidence documents and forms
- Experience managing API Table-A and NERBY tracker
- Experience supporting Health Canada GMP audits and establishment licence queries
- Ability to proactively manage supply-chain risks affecting importation and distribution of healthcare products
- Ability to liaise with global suppliers, clients, internal Quality team, and Health Canada
- Knowledge and experience reviewing Drug and NHP testing requirements in Canada under Food and Drug Regulations and NHP Regulations
Benefits
- Accommodations are available on request for candidates taking part in all aspects of the selection process
- Environment and exposure to pharmaceutical regulatory work
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