Director, CMC Regulatory Affairs

About the role

The Director, CMC Regulatory Affairs role is part of a fast-growing biotechnology environment where you will lead global CMC regulatory strategy for innovative biologic and combination products. You will play a key role in advancing therapies from clinical development through commercialization by ensuring strong regulatory pathways and execution.

Responsibilities

• Provide strategic and operational leadership for global CMC regulatory activities supporting the development, registration, and lifecycle management of biologic and combination products.
• Develop and execute global CMC regulatory strategies for biologic and combination products throughout clinical and commercial development stages.
• Lead preparation and management of regulatory submissions, including INDs, CTAs, IMPDs, BLAs, MAAs, and post-approval filings.
• Prepare regulatory briefing documents, health authority meeting packages, and responses to agency questions.
• Serve as the primary CMC Regulatory lead for cross-functional development teams.
• Provide regulatory guidance related to manufacturing processes, analytical methods, quality attributes, specifications, stability, comparability, and lifecycle management.
• Absess regulatory impacts of manufacturing, process, and product changes while developing effective risk mitigation strategies.
• Support interactions with health authorities, including meetings, submissions, and regulatory communications.
• Collaborate with internal teams and external partners across CMC, Quality Assurance, Supply Chain, Clinical, and other functions.
• Monitor evolving global regulatory requirements and provide strategic guidance on industry trends and regulatory expectations.
• Support product release activities, investigations, inspections, and relevant regulatory procedures.

Requirements

• An experienced CMC regulatory professional with a strong background in biologics development, regulatory strategy, and global submissions.
• Significant experience developing and executing global CMC regulatory strategies for biologic products.
• Deep knowledge of global CMC regulatory requirements and experience with INDs, IMPDs, CTAs, BLAs, MAAs, and post-approval submissions.
• Strong understanding of biologics and combination product development, including manufacturing processes, analytical methods, process validation, comparability, specifications, and stability.
• Experience supporting health authority interactions, regulatory meetings, and responses to agency questions.
• Ability to evaluate regulatory implications of product, process, manufacturing, and lifecycle changes.
• Excellent leadership, project management, communication, and stakeholder collaboration skills.
• Ability to interpret complex scientific and technical data and translate it into effective regulatory strategies.
• Experience with biologics and combination products, including prefilled syringes and autoinjectors, is preferred.
• Ability to work effectively in a remote, cross-functional, and fast-paced environment.

Benefits

Competitive salary range of approximately $210,000 - $235,000, depending on experience, education, and location.
Fully remote work opportunity with occasional travel required for team and company events.
Opportunity to contribute to innovative therapies addressing significant unmet medical needs.
Collaborative environment working with multidisciplinary scientific and regulatory experts.
Professional growth opportunities within a rapidly advancing biotechnology organization.
Opportunity to influence global regulatory strategies and product development programs.
Equal opportunity workplace committed to diversity, inclusion, and belonging.