Senior Manager, CMC Regulatory Affairs (Biologics)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, CMC Regulatory Affairs (Biologics) based in the United States.

This role offers a high-impact opportunity to lead global CMC regulatory strategy for complex biologic products across late-stage development, commercialization, and lifecycle management. The position sits at the core of cross-functional biologics development, ensuring alignment between regulatory requirements and technical execution across manufacturing, quality, and analytical functions. It involves shaping and executing regulatory strategies that support late-stage clinical programs, marketing applications, and post-approval changes across global markets. The role requires close collaboration with technical operations and development teams to ensure robust control strategies, comparability assessments, and regulatory compliance. Acting as a key regulatory leader, the individual will also engage directly with health authorities on CMC matters. This is a strategic role with significant influence on product approvals and global patient access in rare disease therapeutics.

• Develop and execute global CMC regulatory strategies supporting biologics across clinical development, registration, commercialization, and lifecycle management activities.
• Serve as the CMC Regulatory lead on cross-functional teams, providing strategic direction and ensuring alignment with global regulatory requirements and business objectives.
• Lead preparation, review, and submission of CMC documentation for global filings including INDs, IMPDs, CTAs, BLAs, NDAs, MAAs, amendments, supplements, and annual reports.
• Author and review Module 2 and Module 3 sections, ensuring consistency, scientific accuracy, and regulatory compliance across submissions.
• Manage CMC-related Health Authority interactions, including briefing packages, meeting support, and responses to regulatory questions.
• Provide regulatory oversight for manufacturing changes, comparability assessments, process validation, site transfers, and post-approval lifecycle activities.
• Partner with Technical Operations, Manufacturing, Quality, and R&D teams to align CMC development strategies with regulatory expectations.
• Support inspection readiness, regulatory risk assessments, and mitigation planning for global biologics programs.

Requirements:

• Bachelor’s degree in a scientific discipline such as Biology, Chemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, or related field; advanced degree preferred.
• 7+ years of experience in Regulatory Affairs, with strong focus on CMC within the biotechnology or pharmaceutical industry.
• Extensive experience supporting biologics development programs from early-stage through commercialization, including Phase 3 and late-stage programs.
• Proven track record supporting global regulatory submissions (e.g., BLAs, NDAs, MAAs, INDs, IMPDs, CTAs).
• Strong technical understanding of biologics manufacturing processes, including cell culture, purification, formulation, and fill-finish operations.
• Deep knowledge of CMC regulatory requirements, including comparability, process validation, control strategies, and lifecycle management.
• Experience leading Health Authority interactions on CMC topics and supporting global regulatory inspections.
• Strong understanding of analytical characterization, critical quality attributes (CQAs), and quality systems for biologics.
• Ability to develop and execute global CMC regulatory strategies in complex, matrixed environments.
• Strong communication, stakeholder management, and cross-functional collaboration skills.
• Willingness to travel up to 10% domestically and internationally.

Benefits:

• Competitive base salary range: $132,000 – $172,000.
• Short-term incentive bonus and long-term equity (stock) compensation opportunities.
• Comprehensive health, dental, and vision insurance coverage.
• Retirement plan with employer matching contributions.
• Life insurance and disability coverage.
• Generous paid time off and flexible work-life balance support.
• Wellness programs and employee assistance resources.
• Financial, health, and well-being benefits for employees and dependents.