CMC Regulatory Consultant (Biologics Must Have) - Canada Remote Based

We are seeking a CMC Regulatory Consultant (Biologics Must Have) to guide Canadian regulatory submissions for biologics and support life‑cycle activities across rare‑disease product portfolios. The consultant will partner closely with internal stakeholders and Health Canada to ensure submission quality, compliance, and timely responses to regulatory questions. This is a hands‑on, independent role offering local regulatory insight for the Canadian market.

Responsibilities

• Support client submissions to Health Canada for rare‑disease products
• Manage Level III and sNDS submissions effectively
• Update local Module 3 documents as required
• Prepare and submit Annual Drug Notifications
• Coordinate responses to Clarifax queries
• Provide regulatory intelligence specific to the Canadian market
• Work independently on life‑cycle submissions in Canada

Qualifications

• 5–7 years of regulatory experience in biologics or small molecules
• Proven track record with Life Cycle Management (LCM) submissions
• Hands‑on experience with Level III and sNDS submissions
• Strong knowledge of Health Canada submission processes
• Local expertise in regulatory intelligence for Canada
• Excellent skills in CMC (Chemistry, Manufacturing, and Controls) authoring

Benefits

• Fully remote position offering flexibility (US‑based candidates only; no visa sponsorship)
• Opportunity to work with rare‑disease product portfolios
• Engagement in high‑impact regulatory processes
• Collaboration with Health Canada
• Possibility for growth and cross‑functional interactions

Pay

$100,000 – $120,000 annually.