Regulatory Specialist – Canada

Job not on LinkedIn

🔥 13 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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

• 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

• 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