Regulatory Affairs Consultant – CMC, US/EU – Mature Biological Products

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

📋 Description

• Oversee and participate in CMC regulatory strategies for worldwide product lifecycle initiatives, which include variations and post-approval modifications.

• Create and evaluate high-quality CMC documentation for Modules 1-3 tailored for global submissions.

• Assist in and lead global submissions in the US, EU, and other regions from planning through to execution.

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

• Collaborate across various functions with Regulatory, Quality, Manufacturing, and client stakeholders.

• Serve as a vital contributor within a dedicated client team, fostering strong, trustworthy relationships.

• Ensure that submissions fulfill global regulatory requirements with accuracy and excellence.

• Shape CMC regulatory strategy and outcomes as a reliable advisor.

• Engage in lifecycle management activities and foster long-term client partnerships.

⛳️ Requirements

• A minimum of 3 years of experience in CMC Regulatory Affairs or CMC Strategy for a Senior Associate position.

• At least 5 years of experience in CMC Regulatory Affairs or CMC Strategy for a Regulatory Affairs Consultant position.

• Practical experience with commercial biological products and/or vaccines.

• In-depth knowledge of global regulatory standards, including those from the FDA, EMA, and other international markets.

• Demonstrated experience in managing global submissions.

• Proficiency in authoring and reviewing CMC Modules 1-3 to facilitate variations.

• Experience in conducting CMC dossier gap analyses.

• Strengths in CMC regulatory strategy, authoring and reviewing CMC Modules 1-3, and analyzing dossier gaps.

• Background in CMC Regulatory Affairs or CMC Strategy within a regulated biopharmaceutical setting.

• Capability to collaborate across teams, manage stakeholders, and communicate effectively.

• A patient-focused approach, dedication to quality and integrity, and keen attention to detail.

• Comfort with global submission processes and regulatory documentation standards.

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

• Candidates must reside in Canada; flexibility to work Eastern Time hours is essential for those outside Canada's eastern time zone.

🏝️ Benefits

• Comprehensive benefits package for eligible employees.

• Competitive salaries based on position and level offered, skills, education, training, experience, professional achievements, and location.

• Certain roles may qualify for additional incentives, bonuses, or other compensation programs.

• Flexibility, growth opportunities, and an environment to perform at their best.

• Continuous learning opportunities available.

• Global exposure across US, EU, and international regulatory landscapes.