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.

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

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