Canada Local Regulatory Expert — Submissions & Lifecycle

Syneos Health; Canada; On-site; CAD 90,000 - 120,000; Full time

Job summary

Syneos Health is seeking a Local Regulatory Expert for Canadian Lifecycle Maintenance Support. The role focuses on supporting Health Canada submissions for biologic/small molecule products, ensuring lifecycle maintenance and regulatory intelligence in Canada.

You will liaise with Health Canada, coordinate Level III submissions, sNDS, PQRs, and annual drug notifications, and contribute to Clarifax responses while enabling timely product updates across the portfolio.

Qualifications

• Experience with regulatory submissions in Canada would be advantageous but not required to apply.

Responsibilities

• Support Health Canada submissions for a Biologic / Small molecule rare disease product portfolio.
• Coordinate Level III Submissions, sNDS Submissions, PQRs, and Annual Drug Notifications.
• Provide regulatory intelligence for Canada and work independently on lifecycle submissions.
• Assist with Clarifax responses and related regulatory communications.
• Interface with Health Canada as needed to advance submissions.

Job description

Syneos Health is seeking a Local Regulatory Expert for Canadian Lifecycle Maintenance Support. The role focuses on supporting Health Canada submissions for biologic/small molecule products, ensuring lifecycle maintenance and regulatory intelligence in Canada.

You will liaise with Health Canada, coordinate Level III submissions, sNDS, PQRs, and annual drug notifications, and contribute to Clarifax responses while enabling timely product updates across the portfolio.