Director, CMC and Device Regulatory Affairs

Role Summary

The Director, CMC and Device Regulatory Affairs will lead the implementation of global regulatory CMC strategies for drug-device combination products (e.g., prefilled syringes and autoinjectors) across all phases of development through licensure, ensuring compliance with global regulatory requirements. The role requires a strong understanding of regulatory CMC aspects for biologics and/or drug-delivery combination products. This functions as a strategic partner, contributing to strategy development, leading key initiatives, and supporting broader regulatory objectives.

Responsibilities

• Develop and implement global CMC and device regulatory strategies for assigned program(s)
• Lead the preparation and review of CMC and device regulatory submissions (e.g., INDs, CTAs, BLAs, MAAs, Notified Body submissions)
• Collaborate with Technical Operations, Quality, Clinical, and Regulatory teams to ensure regulatory requirements are integrated into product development plans
• Identify regulatory risks associated with product development and propose mitigation strategies
• Manage interactions with regulatory agencies and notified bodies, including meeting preparation and responses to queries
• Review CMC-related changes for potential impact on global submissions, provide regulatory impact assessments, and work with project teams to ensure timely reporting of changes
• Archive and maintain regulatory submissions and correspondences in Apogee’s regulatory information management system
• Contribute to the optimization and implementation of processes and procedures, commensurate with departmental and company growth

Qualifications

• Required: Advanced degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field
• Required: Minimum of 10 years of industry experience, with at least 6 years in CMC regulatory for biologics and/or drug-delivery combination products
• Preferred: Experience with late-stage development (Phase 3) and/or BLA/MAA/Notified Body submissions
• Required: Proven track record of leading cross-functional submission teams and successful regulatory submissions
• Required: Strong knowledge of global regulatory requirements (FDA, EMA, ICH)
• Required: Excellent communication, leadership, and project management skills
• Required: Detail-oriented with ability and desire to work in a fast-paced, nimble, hands-on, team-oriented, biotech environment
• Preferred: Travel up to 15–20% (including in-person attendance at All Hands meetings)
• Required: Demonstrated alignment with C.O.R.E. values: Caring, Original, Resilient, and Egoless

Education

• Advanced degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field

Skills

• Regulatory strategy development
• CMC and device regulatory submissions
• Cross-functional collaboration
• Regulatory risk assessment
• Regulatory agency and Notified Body interactions
• Regulatory information management systems