Associate Director, CMC Regulatory Affairs (Biologics) (Remote

Position Summary

The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial programs. This role leads the development and execution of global CMC regulatory strategies to support clinical development, marketing applications, and lifecycle management activities for biologic products, with a strong focus on late-stage development, Phase 3 programs, and rare disease therapeutics.

The Senior Manager serves as the primary CMC Regulatory Affairs representative on cross-functional teams and partners closely with Technical Operations, Process Development, Pharmaceutical Development, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management to ensure alignment of CMC development plans with global regulatory requirements and business objectives.

This position requires extensive experience supporting biologics development programs and a strong technical understanding of biologic drug substance and drug product manufacturing, analytical characterization, process development, comparability, and control strategies. The individual will be responsible for driving CMC regulatory submissions, managing Health Authority interactions related to CMC topics, assessing regulatory risks, and supporting successful product approvals and post-approval activities worldwide.

• Develop and implement global CMC regulatory strategies to support clinical development, registration, commercialization, and lifecycle management of biologic products.
• Serve as the CMC Regulatory lead on cross-functional program teams, providing strategic regulatory guidance throughout product development.
• Assess regulatory risks, develop mitigation strategies, and provide regulatory recommendations to support program goals and business priorities.
• Contribute to regulatory strategy development for expedited development programs, orphan drug products, and rare disease indications.
• Lead preparation, review, and submission of CMC documentation for global regulatory filings, including INDs, IMPDs, CTAs, BLAs, NDAs, MAAs, amendments, supplements, variations, and annual reports.
• Author and review Module 2 and Module 3 content and ensure consistency across submission components.
• Coordinate cross-functional contributions to CMC regulatory submissions and ensure compliance with global regulatory requirements and submission standards.
• Support preparation for major registration milestones, including first marketing applications and global expansion filings.
• Lead CMC‑related Health Authority interactions and support agency meetings globally.
• Support inspection readiness and regulatory assessments related to manufacturing and product quality.
• Develop global regulatory filing strategies for lifecycle management activities and post‑approval CMC changes, including manufacturing process changes, analytical method updates, specification revisions, site transfers, process validation, and comparability assessments.

• Provide regulatory guidance and strategic input for biologics development programs, including monoclonal antibodies (mAbs), recombinant proteins, fusion proteins, and other complex biologic modalities.
• Collaborate with development and manufacturing teams to support regulatory strategies related to cell line development, upstream and downstream process development, scale‑up, process validation, and commercial manufacturing.
• Evaluate regulatory impact of manufacturing changes involving microbial and mammalian cell culture processes, purification operations, formulation development, fill‑finish activities, and technology transfers.
• Support development and regulatory assessment of comparability strategies for manufacturing process changes, site transfers, process improvements, and lifecycle management activities.
• Provide regulatory oversight and strategic guidance for analytical characterization programs and control strategies supporting product quality,…