Senior Regulatory Affairs CMC Associate/Consultant – Biologics, Vaccines

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

📋 Description

• Lead and play a vital role in developing CMC regulatory strategies for global product lifecycle activities, encompassing variations and post-approval changes.

• Author and critique high-quality CMC documentation (Modules 1–3) for worldwide submissions.

• Conduct CMC dossier gap analyses and provide clear, strategic recommendations.

• Oversee and support global submissions (US, EU, and beyond) from the planning stage through to execution.

• Collaborate cross-functionally with Regulatory, Quality, Manufacturing, and client stakeholders.

• Serve as a key contributor within a dedicated client team, fostering strong, trusted relationships.

• Ensure that submissions adhere to global regulatory expectations with precision and excellence.

⛳️ Requirements

• A minimum of 3 years of experience in CMC Regulatory Affairs or CMC Strategy for a Senior Associate role, and at least 5 years of experience for a Regulatory Affairs Consultant role.

• Practical experience with commercial biologicals and/or vaccines (mandatory).

• Strong understanding of global regulatory requirements (FDA, EMA, and international markets).

• Demonstrated experience in managing global submissions.

• Proficiency in authoring/reviewing CMC Modules 1–3 to support variations and conducting gap analyses.

• A collaborative mindset accompanied by strong communication and stakeholder management skills.

• Familiarity with Veeva Vault (RIM/eCTD systems) is advantageous.

🏝️ Benefits

• Meaningful Work: Contribute to innovative biologics and vaccines that enhance patient lives on a global scale.

• Dedicated Client Partnership: Cultivate deeper relationships and create long-term impact—not just project-oriented work.

• Global Exposure: Acquire experience across US, EU, and international regulatory environments.

• Growth & Influence: Be recognized as a strategic partner and expand your expertise in a high-visibility role.