Regulatory Project Manager, Strategy – CMC RA Molecules Products

• Provide CMC support to a defined portfolio of marketed small-molecule drug substances and products for global markets
• Maintain global regulatory information for assigned products by leading CMC Regulatory Matrix teams and representing CMC in cross-functional Regulatory Matrix Teams
• Partner with Technical, Quality, manufacturing, and other cross-functional teams to provide strategic regulatory advice for change controls
• Develop regulatory strategies and plans through implementation
• Lead authoring of variation dossiers and responses to Regulatory Agency questions
• Develop CMC strategy for submission documents supporting marketed product lifecycle management
• Ensure lifecycle maintenance submissions meet regional requirements and support supply, production, and quality flexibility
• Prepare, review, and quality-check CMC content for regulatory filings, post-approval variations, and maintenance submissions
• Act as primary U.S. regulatory contact for agency interactions, written questions, and meeting preparation
• Advise cross-functional teams on U.S. and global CMC regulatory requirements and timelines to support supply continuity
• Identify regulatory gaps, propose mitigations, and coordinate actions with stakeholders
• Maintain regulatory compliance and share best practices and learnings
• Provide CMC subject matter expertise and support continuous improvement of regulatory processes

• Bachelor’s degree in pharmacy, chemistry, pharmaceutical sciences, or related scientific discipline, or equivalent experience
• Minimum of 2 years’ experience in CMC regulatory affairs focused on small molecules, including lifecycle management and post-approval activities or closely related discipline
• Direct experience preparing or contributing to CMC sections of regulatory submissions for the U.S. market
• Six or more months experience with U.S. regulatory requirements and guidance relevant to CMC, including Good Manufacturing Practices
• Experience leading U.S. regulatory interactions and meeting preparation with the FDA
• Demonstrated ability to work in cross-functional teams with development, manufacturing and quality colleagues
• Strong written and verbal communication skills with attention to detail
• Experience managing multiple product dossiers and competing priorities in a matrix environment
• Experience supporting inspections or providing regulatory input for manufacturing changes
• Knowledge of electronic dossier formats and submission processes
• Proven ability to influence stakeholders and negotiate technical-regulatory resolutions

Demonstrates expertise in CMC regulatory affairs for small molecules, including lifecycle management and regulatory submissions. Proven ability to collaborate with cross-functional teams and maintain compliance with U.S. regulatory requirements.

• CMC Regulatory Affairs
• Regulatory Submissions
• U.S. Regulatory Requirements
• Good Manufacturing Practices
• Cross-Functional Collaboration

• Regulatory Strategy Development
• Variation Dossier Authoring
• Lifecycle Management
• Regulatory Compliance
• Regulatory Agency Interaction
• Quality-Check CMC Content
• Electronic Dossier Formats
• Post-Approval Activities
• Change Control Management
• Regulatory Gap Identification

• Strong Written Communication
• Strong Verbal Communication
• Attention to Detail
• Influencing Stakeholders
• Negotiation Skills

• Pharmacy
• Chemistry
• Pharmaceutical Sciences
• Small Molecules
• Regulatory Matrix Teams
• FDA Interactions
• Matrix Environment
• Continuous Improvement
• Best Practices
• Manufacturing Changes