Sr. Manager, Regulatory Affairs CMC

Role Summary

The Sr. Manager, Regulatory Affairs CMC will oversee and execute regulatory CMC strategy for drug-device combination products, supporting Product Development and Quality Teams, managing periodic reporting and regulatory submissions for new and marketed products, and providing strategic regulatory guidance to project teams.

Responsibilities

• Develop regulatory CMC strategy for drug-device combination products, including authoring and reviewing regulatory submissions (INDs, NDAs, DMFs, etc.) and reviewing product, manufacturing, and quality documentation (specifications, development reports, protocols, NCRs, CAPAs, etc.).
• Support labeling generation, updates, and implementation for both new development and updates to approved labeling, including Prescribing Information, Instructions for Use, and packaging components.
• Lead and/or participate in development of CMC-related change controls; evaluate regulatory and quality documentation impact of post-approval changes and develop plans for implementation, including regulatory submissions.
• Manage preparation and submission of periodic reports, including annual reports to regulatory bodies as applicable.
• Collaborate with Regulatory and Quality Management to manage field action reporting, product recalls, and associated communications if products do not meet quality requirements.
• Identify and implement improvements in CMC-related procedures to enhance efficiency and maintain regulatory compliance with evolving requirements.

Qualifications

• Bachelor‚Äôs in a relevant scientific discipline (Chemistry, Chemical Engineering, Pharmaceutical Development, etc.) with 7‚Äì10 years‚Äô experience in product development/manufacturing, CMC, regulatory, or quality; advanced degree and/or cross-functional experience preferred.
• Expertise in CMC-related regulatory requirements, FDA guidances, and standards; experience with drug-device combination products preferred.
• Experience with preparation and review of regulatory submissions, including US and international documents (INDs/CTAs, NDAs/MAAs, etc.).
• Knowledge of post-approval product and manufacturing change assessments for drug-device combinations; good manufacturing and documentation practices.
• Knowledge of project management tools and techniques to ensure timely, multidisciplinary deliverables.

Skills

• Regulatory strategy and submission management for CMC
• Cross-functional collaboration and stakeholder management
• Change control and post-approval amendment planning
• Labeling development and regulatory labeling requirements
• Process improvement and regulatory trend analysis

Education

• Bachelors in a relevant scientific discipline; advanced degree preferred

Additional Requirements

• Up to 20% travel; travel to vendor/manufacturing facilities for observations, investigations, and audits