Manager, Regulatory Affairs CMC

Job Responsibilities

• Support preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs, supplements, and variations)
• Contribute to Module 3 (CMC) content development, ensuring alignment with global regulatory requirements
• Assist in execution of global CMC regulatory strategies under guidance of senior staff
• Partner with cross-functional teams (e.g., Technical Operations, MSAT, Quality, Manufacturing, Supply Chain) to support regulatory deliverables
• Support health authority interactions, including preparation of responses to information requests (IRs/RTQs) and meeting materials
• Assess change controls for regulatory impact and support lifecycle management activities
• Support activities related to manufacturing changes, comparability, and site updates
• Contribute to inspection readiness activities, including preparation of supporting documentation
• Maintain accurate regulatory records and documentation in relevant systems
• Identify and escalate risks and contribute to mitigation strategies
• Participate in continuous improvement initiatives and knowledge-sharing activities

Basic Qualifications

• Bachelor’s degree in a scientific discipline with 6+ years of relevant experience; OR
• Master’s degree with 4+ years of relevant experience

Preferred Qualifications

• Degree in life sciences, biotechnology, pharmaceutical sciences, or related field
• Experience in Regulatory Affairs CMC within biotech or pharmaceutical industry
• Experience supporting regulatory submissions and lifecycle management
• Familiarity with GMP and manufacturing processes
• Basic understanding of comparability and manufacturing changes

Scope and Impact

Supports regulatory activities for assigned programs under guidance
Contributes to timely delivery of regulatory submissions and responses
Builds foundational expertise in Regulatory CMC

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.