Manager, Regulatory Affairs CMC

Responsibilities

• Support preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs, supplements, and variations), including submissions supporting lentiviral vector (LVV) manufacturing, testing, control strategy, and lifecycle management.
• Contribute to Module 3 (CMC) content development, ensuring alignment with global regulatory requirements for cell therapy products and associated LVV and critical raw materials.
• Assist in execution of global CMC regulatory strategies under guidance of senior staff for both cell therapy products and lentiviral vector manufacturing platforms.
• Partner with cross-functional teams (e.g., Process Design, MSAT, Quality, Manufacturing, Supply Chain) to support regulatory deliverables related to LVV process development, manufacturing, analytical testing, comparability, and supply continuity.
• Support health authority interactions, including preparation of responses to information requests (IRs/RTQs) and meeting materials related to LVV manufacturing processes, control strategy, potency, safety testing, and process validation.
• Assess change controls for regulatory impact and support lifecycle management activities including changes associated with LVV manufacturing processes, raw materials, analytical methods, manufacturing sites, and production scale.
• Support activities related to manufacturing changes, comparability, and site updates for both cell therapy and LVV manufacturing operations.
• Contribute to inspection readiness activities, including preparation of supporting documentation for LVV and cell therapy manufacturing facilities.
• Maintain accurate regulatory records and documentation in relevant systems related to LVV manufacturing, supply, regulatory compliance, and health authority commitments.
• Identify and escalate risks and contribute to mitigation strategies focused on evolving global regulatory expectations for gene-modified cell therapies and viral vectors.
• Participate in continuous improvement initiatives and knowledge-sharing activities.

Knowledge, Skills, and Abilities

• Foundational knowledge of CMC regulatory requirements and ICH guidelines.
• Strong written and verbal communication skills.
• Attention to detail and strong organizational skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Effective cross-functional collaboration.
• Proactive and solution-oriented mindset.

Core Competencies

• Working knowledge of lentiviral vector manufacturing processes, process controls, critical quality attributes (CQAs), and analytical characterization approaches.
• Understanding of regulatory expectations for viral vector comparability, process validation, control strategy development, and post-approval lifecycle management.
• Knowledge of global regulatory requirements and emerging guidance applicable to cell and gene therapy products, including viral vector starting materials.
• Ability to assess manufacturing changes and interpret their potential regulatory impact on LVV quality, safety, potency, and supply continuity.

Basic Qualifications

Bachelor’s degree with Six Years' experience OR Master’s degree with Four Years' experience.

Preferred Qualifications

• Degree in a scientific discipline.
• Experience with cell and gene therapy / CAR-T / ATMP programs, including substantial experience with lentiviral vectors (LVV), viral vector manufacturing, characterization, control strategies, and lifecycle management.
• Experience supporting regulatory submissions and health authority interactions.
• Knowledge of regulatory expectations for replication-competent lentivirus (RCL), vector safety assessments, adventitious agent control, and viral vector product characterization.
• Experience supporting internal or contract manufacturing organizations (CMOs) involved in LVV production and supply chain management.