Director Regulatory CMC

The Director, Regulatory CMC will lead the development and execution of global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies to support the development, registration, and lifecycle management of biologic oncology products. This role will serve as the primary CMC regulatory interface with internal teams and global health authorities, ensuring compliance with evolving regulatory requirements.

Key Responsibilities

• Develop and implement global CMC regulatory strategies for biologics products from early development through post-approval.

• Oversee the preparation, review, and submission of high-quality CMC sections of regulatory filings (INDs, IMPDs, BLAs, MAAs, amendments, supplements) in compliance with global regulatory requirements.
• Serve as the primary CMC regulatory representative on cross-functional project teams, including Clinical, Quality, Manufacturing, and Program Management, to ensure integrated development strategies.
• Provide strategic input into process development, analytical method validation, comparability protocols, and control strategies to support late-stage development and commercial readiness.
• Lead regulatory interactions with global health authorities (e.g., FDA, EMA, MHRA), including the preparation of briefing documents, responses to information requests, and participation in meetings.
• Anticipate and proactively manage CMC regulatory risks, including gap assessments and mitigation strategies for late-phase and pre-commercial programs.
• Collaborate with internal and external manufacturing partners (CDMOs/CMOs) to ensure regulatory compliance and readiness for inspections and submissions.
• Monitor and analyze regulatory agency activities regarding CMC development and assess potential impact on development programs and stay abreast of the regulatory landscape.
• Assume a global view of CMC regulatory strategy and help teams navigate regional requirements and the potential interplay between key regulatory agencies.
• Support the development and maintenance of regulatory CMC policies, procedures, and best practices to ensure operational excellence and compliance.
• Contribute to regulatory due diligence activities for potential in-licensing or partnership opportunities, particularly in the oncology space.
• Mentor and guide junior regulatory staff, fostering a culture of collaboration, accountability, and continuous improvement.

Qualifications

• Advanced degree (PhD, PharmD, MS) in a scientific discipline (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences).
• Minimum of 10 years of experience in Regulatory Affairs with a focus on CMC for biologics
• Proven track record of leading CMC regulatory strategy and submissions in major markets (US, EU, Canada, Australia, Japan).
• Strong knowledge of global regulatory requirements and guidelines (ICH, FDA, EMA, etc.).
• Experience interacting with regulatory agencies and managing agency responses.
• Excellent communication, leadership, and project management skills.