Senior Director CMC Regulatory Affairs

Role Summary

The Senior Director CMC Regulatory Affairs will lead global CMC regulatory strategy for biologics programs, drive planning and submission of CMC documentation (INDs, CTAs, NDAs/BLA, MAAs) to global health authorities, and oversee interactions with FDA and other agencies. The role partners with Quality, Project Management, Supply Chain, and Technical Operations to ensure timely submissions and regulatory milestones. It provides strategic and hands-on leadership to the regulatory and manufacturing teams, develops policies aligned with GxP and regulatory guidance, and maintains up-to-date knowledge of global requirements. This is a remote-based role with 10–20% travel expected.

Responsibilities

• Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks; ensure global CMC regulatory requirements and strategy are understood by project teams.
• Plan, prepare, and coordinate CMC documents for global regulatory submissions (INDs, CTAs/IMPDs, BLAs, MAAs, amendments, annual updates, briefing documents) and responses to Agency queries.
• Partner with internal and external cross-functional teams to meet submission deadlines and timely approvals of CMC-related applications.
• Lead and support interactions with FDA and other health authorities for CMC-related topics.
• Communicate project updates and risks to senior management; track regulatory commitments and deliverables.
• Maintain up-to-date knowledge of global regulatory requirements.
• Initiate and contribute to the development of policies and procedures in alignment with GxPs, global regulatory requirements and guidance, and corporate objectives.
• Provide hands-on leadership to the regulatory and manufacturing team in planning, preparing, and coordinating CMC documents submitted to global authorities.
• Communicate with CMC management and leadership on CMC filing strategies; summarize regulatory strategy and associated risks collaboratively.
• Build strong stakeholder partnerships with Quality, Project Management, Supply Chain, and CMC to enable open, robust discussions for sound scientific decisions.
• Communicate project updates and risks to senior management and stakeholders; interact effectively and independently with consultants.
• Establish an integrated CMC regulatory strategy that anticipates risk and aligns with enterprise objectives; secure cross-functional alignment across Technical Operations, Quality, and Program leadership.
• Provide leadership across CMC strategy and supervision; manage the CMC team and contractors, and coach/mentor staff.

Qualifications

• 12+ years of biopharmaceutical experience, which includes at least 6 years of direct experience in Regulatory Affairs CMC.
• Demonstrated, hands-on experience in biologics drug development, registration, and post-approval life cycle management in a global environment; direct involvement with parenteral products, including drug-device combination development.
• Comprehensive understanding of CMC product development with biologics and drug-device combinations and knowledge of applicable global regulations, guidance, and practices.
• Experience in the preparation and submission of global regulatory dossiers (including IND/CTA/NDA/BLA/MAA), briefing documents, and agency queries; recent and relevant BLA filing experiences.
• Prior experience leading interactions with global regulatory authorities on CMC-related issues.
• Strategic and analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Strong leadership in working with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and external vendors and contract organizations.
• Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal and external audiences including executive leadership.
• Ability to thrive in a collaborative and fast-paced environment.
• Specialized knowledge: track record of successful IND, CTA, NDA/BLA, and MAA submissions; knowledge of GxP, ICH, FDA, EMA and other global regulations and guidance; attention to detail and ability to balance analytical and critical-thinking skills to develop data-driven, strategically oriented regulatory proposals; strong experience leading regulatory CMC strategy for biologics and drug-device development programs.

Education

• Masters or PhD degree in a relevant scientific discipline; advanced degree preferred

Additional Requirements

• Remote-based work environment; dynamic, interactive, fast-paced, entrepreneurial setting.
• Domestic or international travel required (10–20%).