Regulatory Specialist – Canada

This is a fully remote position, open to applicants in Canada.

📋 Description

• Assist clients with submissions to Health Canada for a portfolio of biologic/small molecule products related to rare diseases.

• Support lifecycle management submissions within Canada.

• Prepare or assist with Level III submissions.

• Prepare or assist with sNDS submissions.

• Manage PQRs.

• Oversee annual drug notifications.

• Coordinate responses for Clarifax inquiries.

• Engage directly with Health Canada.

• Provide insights on local Canadian regulatory matters.

• Operate independently on Canadian lifecycle submissions.

⛳️ Requirements

• Proven experience in supporting client submissions to Health Canada for a biologic/small molecule portfolio focused on rare diseases.

• Significant experience in lifecycle management submissions, encompassing Level III submissions, sNDS submissions, PQRs, annual drug notifications, and coordinating responses to Clarifax inquiries.

• Direct experience interacting with Health Canada is essential.

• Capability to provide local regulatory intelligence for Canada.

• Ability to work independently while supporting lifecycle submissions in Canada.

• Experience in CMC biologic authoring is advantageous.

• Equivalent experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Commitment to an inclusive culture.

• Reasonable accommodations provided, when appropriate, for employees or applicants with disabilities.