CMC Regulatory Consultant, Biologics

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

📋 Description

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

• Prepare and provide support for Level III submissions.

• Aid in sNDS submissions, which includes updating local Module 3 documentation.

• Support the preparation of PQRs and Annual Drug Notifications.

• Coordinate responses for Clarifax queries.

• Engage directly with Health Canada officials.

• Offer regulatory intelligence pertinent to Canada.

• Operate independently on life-cycle submissions within Canada.

⛳️ Requirements

• Experience in biologics is mandatory.

• Proven experience in supporting submissions to Health Canada for biologic/small molecule products in the rare disease category.

• Essential experience in life-cycle management submissions, including Level III submissions, sNDS submissions, updates to local Module 3 documents, PQRs, Annual Drug Notifications, and coordinating Clarifax responses.

• Direct experience interacting with Health Canada is required.

• Experience in CMC authoring is necessary.

• Capability to provide local regulatory intelligence for Canada.

• Ability to work independently while supporting life-cycle submissions in Canada.

• Equivalent experience, skills, and/or education may be considered.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and involved line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

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