Senior Director, CMC Regulatory Affairs

This role is responsible for leading global CMC regulatory strategy, ensuring compliance, and enabling successful development and commercialization of complex biologic and cell-based products.

• Lead the development and execution of global CMC regulatory strategies aligned with product development, manufacturing, and corporate objectives.
• Oversee preparation, review, and approval of regulatory submissions including IND, IMPD, BLA, MAA, and other filings.
• Serve as primary CMC regulatory representative in interactions with the FDA and international regulatory authorities.
• Lead and mentor the Regulatory CMC team, providing guidance, oversight, and professional development.
• Partner with Manufacturing, MSAT, Quality Assurance, and Process Development to ensure regulatory alignment across all operations.
• Identify regulatory risks and develop mitigation strategies in collaboration with senior leadership.
• Ensure compliance with global regulatory frameworks, including ICH guidelines, FDA regulations, and EU directives.
• Support regulatory inspections, including preparation, execution, and resolution of findings.
• Maintain and improve regulatory policies and procedures related to biologics and human cell and tissue-based products.

Requirements

This position requires deep expertise in CMC regulatory affairs within biologics, cell therapy, or advanced therapeutic development environments, along with proven leadership experience.

• 8+ years of senior-level experience in Regulatory CMC within biotechnology, biologics, or cell and gene therapy sectors.
• Strong track record of leading regulatory strategy and submissions across preclinical, clinical, and commercial stages.
• Deep knowledge of global regulatory frameworks, including FDA, EMA, ICH guidelines, and human cell and tissue regulations.
• Proven experience supporting and leading regulatory inspections, including FDA and international health authority interactions.
• Demonstrated ability to collaborate across Manufacturing, Quality, MSAT, and Development functions in complex environments.
• Experience managing and mentoring regulatory teams with a leadership mindset.
• Strong written and verbal communication skills, with ability to represent organizations in high-stakes regulatory discussions.
• High attention to detail, strong organizational skills, and ability to manage multiple priorities in fast-paced environments.
• Bachelor’s degree in biology, chemistry, biochemistry, microbiology, biotechnology, or related field required; advanced degree preferred.
• Strong strategic thinking, problem-solving ability, and adaptability in evolving regulatory landscapes.

Benefits

• Competitive base salary with bonus eligibility
• Stock options
• 401(k) plan with employer match and no vesting schedule
• Comprehensive medical, dental, and vision insurance
• Company-paid short-term and long-term disability coverage
• Company-paid life insurance
• Additional voluntary benefits including pet insurance, legal protection, and critical illness coverage
• 23 days of paid time off plus holidays and floating holidays
• Paid parental leave
• Exposure to cutting-edge biologics and advanced therapy development programs
• High-impact leadership role in a mission-driven, innovation-focused environment