Regulatory Specialist – Canada

Syneos Health

. Support client submissions to Health Canada for a biologic/small molecule rare disease product portfolio .

Posted 9/15/2026full-timeRemote • CanadaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in supporting client submissions to Health Canada for biologic and small molecule products, with a strong focus on lifecycle management and regulatory intelligence. Capable of working independently on complex submissions and interactions with regulatory authorities.

Highest-signal resume keywords

Client Submissions To Health CanadaLifecycle Management SubmissionsLevel III SubmissionsSNDS SubmissionsRegulatory Intelligence

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Biologic AuthoringPQR HandlingAnnual Drug NotificationsClarifax CoordinationSelf-Sufficient Work

Industry Keywords

Rare Disease Product PortfolioHealth CanadaCanadian Regulatory Submissions

About the role

Key responsibilities & impact

Support client submissions to Health Canada for a biologic/small molecule rare disease product portfolio
Support lifecycle management submissions in Canada
Prepare or support Level III submissions
Prepare or support sNDS submissions
Handle PQRs
Handle annual drug notifications
Coordinate Clarifax responses
Interact directly with Health Canada
Provide local Canadian regulatory intelligence
Work self-sufficiently on Canadian lifecycle submissions

Requirements

What you’ll need

Experience supporting client submissions to Health Canada for a biologic/small molecule rare disease product portfolio
Essential experience with lifecycle management submissions, including Level III submissions, sNDS submissions, PQRs, annual drug notifications, and coordinating Clarifax responses
Essential experience with direct interaction with Health Canada
Ability to provide local Canada regulatory intelligence
Ability to work self-sufficiently in supporting lifecycle submissions in Canada
CMC biologic authoring experience is an advantage
Equivalent experience, skills, and/or education will also be considered

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Reasonable accommodations, when appropriate, for employees or applicants with disabilities