Manager, Regulatory Affairs – CMC

This is a fully remote position, open to applicants in Canada, +1 more country.

📋 Description

• Create and compose CMC-specific regulatory dossiers, encompassing sections 3.2.S and 3.2.P.

• Develop ICH-compliant CMC/technical elements for global regulatory submissions spanning early to late-stage and post-approval programs.

• Organize and prepare or modify eCTD Module 2.3 and Module 3 documentation for INDs, IMPDs, NDAs, BLAs, MAAs, CTAs, post-approval supplements, and variation submissions.

• Ensure the accuracy, completeness, and timely submission of regulatory documents.

• Plan, monitor, and effectively draft Module 3 documentation utilizing regulatory domain systems and processes such as Veeva.

• Track and interpret changing CMC regulatory requirements, including ICH, US FDA CFRs, EMA Directives, and Annexes.

• Ensure compliance of CMC documentation and data with relevant regulations.

• Collaborate with Quality Assurance, CMC/Manufacturing, and preclinical teams regarding the CMC regulatory scope and content.

• Provide regulatory evaluations for manufacturing changes, which include site transfers, scale-up initiatives, and process modifications.

• Conduct comparability assessments and develop post-approval supplements as necessary.

• Identify potential CMC regulatory risks and propose mitigation strategies.

⛳️ Requirements

• A bachelor's degree is required.

• An advanced degree (M.Sc., Ph.D.) in Biological Sciences, Engineering, or a related field is preferred.

• 7+ years of experience with a strong emphasis on CMC within the radiopharmaceutical or biopharmaceutical sector.

• Comprehensive understanding of global CMC regulatory requirements and guidelines, including ICH guidelines and regulations from the FDA, EMA, and other health authorities.

• Exceptional technical writing and verbal communication abilities.

• Capacity to convey complex regulatory matters to both internal and external stakeholders.

• Strong analytical and problem-solving capabilities.

• Proficiency in assessing and mitigating regulatory risks.

• Ability to collaborate effectively and foster strong relationships across various functions and locations.

• Skilled in summarizing reports and data related to pharmaceutical manufacturing and method development into suitable Module 3 subsections.

• Capability to adapt in a dynamic environment, respond to shifting priorities, and embrace new challenges.

• Dedication to continuous learning and professional growth.

🏝️ Benefits

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development opportunities.

• Hybrid and remote work arrangements available across the organization.