Senior Manager, Regulatory Affairs, CMC

Role Summary

We are seeking a Senior Manager of Regulatory Affairs, CMC who will report into the Associate Director of Regulatory Affairs. You will collaborate with internal teams and external contractors to provide regulatory guidance for oncology product development, establishing standards and managing high-quality CMC regulatory submissions.

Responsibilities

• As a member of the CMC project teams, provide strategic CMC regulatory leadership to support global development and commercialization of drug candidates.
• Write and maintain CMC sections of INDs and IMPD‚Äôs for global CTAs, ensuring complete, compliant, and timely submissions.
• Generate and oversee compilation, review, approval and submission of CMC sections of INDs/CTAs, NDA/MAA, including responses to regulatory questions, collaborating with SMEs in Pharmaceutical Development, QC/QA, Supply Chain and other CMC partners.
• Manage all CMC regulatory timelines, develop submission timelines (IND/CTA/IMPD, NDA/MAA), update tracking tools, communicate, and escalate issues to ensure on-time filings.
• Act as regulatory representative on clinical study teams and product development teams, providing guidance on regulatory CMC matters.
• Evaluate proposed manufacturing changes for global impact and provide strategic regulatory guidance for implementation.
• Provide regulatory support for quality systems (change control, discrepancy management, inspection management) and assess proposed CMC changes for global implementation.
• Monitor regulatory intelligence to assess changes to CMC regulations and their impact on processes and strategy.
• Interact with vendors for electronic publishing and other regulatory operations as needed.
• Perform detailed quality reviews of submitted outputs to ensure compliance with Regulatory Standards.
• Track and archive submissions, correspondence, and commitments with health authorities.
• Develop and maintain SOPs, templates, and style guides as appropriate.
• Ensure adherence to applicable government regulations and submission guidelines.
• Other duties as assigned.

Qualifications

• Bachelor‚Äôs degree in a science or health-related field; or relevant experience; preferred.
• Eight plus (8+) years of submission/publishing Regulatory Affairs, Regulatory Operations, or Regulatory Project Management experience in biotech/pharma.
• Excellent command of GXPs (GMPs, GLPs, GCPs).
• Cross-functional understanding of drug development.
• Understanding of ICH and FDA guidance related to electronic regulatory submissions.
• Experience with global regulatory submissions and focus on electronic publishing of US IND/NDA; CTA/MAA experience is helpful.
• Ability to work independently and in project teams, with strong end-to-end delivery.
• Excellent verbal and written communication, strong organization, and ability to prioritize
• Strong interpersonal skills and ability to work with others.
• Ability to meet deadlines in a fast-paced setting; professional and positive attitude.

Skills

• Regulatory strategy and leadership
• CMC documentation and submissions
• Regulatory intelligence and impact assessment
• Electronic publishing and regulatory systems
• Quality systems knowledge (change control, discrepancy management, inspection management)
• Cross-functional collaboration and project management

Education

• Bachelor‚Äôs degree in science or health-related field; relevant experience acceptable