Regulatory Project Manager, Strategy – CMC RA Small Molecules Mature Products

Jobtailor; North Carolina; On-site; USD 90,000 - 140,000; Full time

Job summary

Jobtailor in North Carolina seeks an experienced CMC Regulatory Affairs professional to lead US lifecycle management for small molecules. You will develop strategies, author variation dossiers, and coordinate with cross‑functional teams to ensure timely regulatory submissions.

You will interact with the FDA, navigate cross‑functional matrix structures, maintain regulatory compliance, and mentor junior staff while driving continuous improvement of processes.

Qualifications

• 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.
• Direct experience preparing or contributing to CMC sections of regulatory submissions for the U.S. market.

Responsibilities

• 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.
• Partner with 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 and meeting preparation.
• Advise cross-functional teams on U.S. and global CMC regulatory requirements and timelines.
• 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.

Skills

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

Education

Bachelor’s degree in pharmacy, chemistry, pharmaceutical sciences, or related scientific discipline

Job description

• 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

Requirements

• 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

Core Competencies

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.

Highest-signal resume keywords

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

Hard Skills

• 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

Soft Skills

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

Industry Keywords

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