Regulatory Affairs CMC Senior Associate / Consultant - Biologics or Vaccines

The role involves shaping global regulatory strategies for biologics and vaccines, contributing to patient outcomes through clinical development and lifecycle management.

Location: Canada

Responsibilities

• Lead and contribute to CMC regulatory strategies for global product lifecycle activities, including variations and post-approval changes
• Author and review high-quality CMC documentation (Modules 1–3) for global submissions
• Perform CMC dossier gap analyses and provide strategic recommendations
• Support and lead global submissions (US, EU, and beyond) from planning through execution
• Partner cross-functionally with Regulatory, Quality, Manufacturing, and client stakeholders
• Act as a key contributor within a dedicated client team, building strong, trusted relationships
• Ensure submissions meet global regulatory expectations with precision and excellence

Requirements

• 3+ years of experience in CMC Regulatory Affairs or CMC Strategy for a Senior Associate role and 5+ years of experience for a Regulatory Affairs Consultant role
• Hands-on experience with commercial biologicals and/or vaccines
• Strong knowledge of global regulatory requirements (FDA, EMA, and international markets)
• Proven experience in global submission management
• Expertise in authoring/reviewing CMC Modules 1–3 to support variations and performing gap analyses
• A collaborative mindset with strong communication and stakeholder management skills
• Experience with Veeva Vault (RIM/eCTD systems) is a plus

Benefits

• Build deeper relationships and drive long-term impact
• Contribute to biologics and vaccines that improve patient lives globally
• Gain experience across US, EU, and international regulatory landscapes
• Grow your expertise in a high-visibility role

Additional Information

• The role offers an opportunity to become a trusted advisor, influence strategy, and see your work directly contribute to patient outcomes.
• The company values patient focus, quality & integrity, respect & teamwork, and innovation.