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CMC Regulatory Consultant, Biologics
Syneos Health. Support client submissions to Health Canada for a biologic/small molecule rare disease product portfolio .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in supporting submissions to Health Canada for biologic and small molecule rare disease products, with a strong focus on life-cycle management and regulatory intelligence. Proficient in CMC authoring and direct interactions with regulatory bodies.
Highest-signal resume keywords
Biologics ExperienceLife-Cycle Management SubmissionsHealth Canada SubmissionsCMC Authoring ExperienceRegulatory Intelligence
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Level III SubmissionsSNDS SubmissionsLocal Module 3 Document UpdatesPQRsAnnual Drug NotificationsClarifax Responses Coordination
Soft Skills
Self-SufficiencyDirect Interaction
Industry Keywords
Regulatory SubmissionsRare Disease ProductsHealth Canada
About the role
Key responsibilities & impact- Support client submissions to Health Canada for a biologic/small molecule rare disease product portfolio
- Prepare and support Level III submissions
- Support sNDS submissions, including updating local Module 3 documents
- Support PQRs and Annual Drug Notifications
- Coordinate Clarifax responses
- Interact directly with Health Canada
- Provide local Canada regulatory intelligence
- Work self-sufficiently on life-cycle submissions in Canada
Requirements
What you’ll need- Biologics experience required
- Experience supporting submissions to Health Canada for biologic/small molecule rare disease products
- Essential experience with life-cycle management submissions, including Level III submissions, sNDS submissions, local Module 3 document updates, PQRs, Annual Drug Notifications, and coordinating Clarifax responses
- Direct interaction experience with Health Canada required
- CMC authoring experience required
- Ability to provide local Canada regulatory intelligence
- Ability to work self-sufficiently in supporting life-cycle submissions in Canada
- Equivalent experience, skills, and/or education may 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