Regulatory Specialist – Canada
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Job Description
Local Regulatory specialist supporting Health Canada lifecycle submissions for biologic and small molecule rare disease products. Providing Canadian regulatory intelligence and coordinating Health Canada interactions.
Responsibilities:
- 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
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