Sr. Director, Regulatory Affairs - CMC

What You'll Do

Lead CMC regulatory strategy and execution across development and post-approval programs, ensuring high-quality submissions aligned with global regulatory requirements. Serve as a strategic Regulatory CMC subject-matter expert and key cross-functional partner, influencing regulatory decision-making and program execution. This role is primarily an individual contributor position with the opportunity to mentor, coach, and potentially manage team members as organizational needs evolve. The ideal candidate brings deep Regulatory CMC expertise, strong cross-functional leadership skills, demonstrated experience with global and ROW filings (e.g., MENA, LATAM, APAC), and practical fluency leveraging AI-enabled and digital tools to improve regulatory workflows and deliverables.

Responsibilities

• Lead CMC regulatory strategy, planning, and execution for IND/CTA, NDA/MAA, post-approval submissions, and global registrations across development programs

• Partner closely with CMC, Quality, Regulatory Operations, and cross-functional stakeholders to ensure timely, high-quality regulatory submissions aligned with global health authority expectations

• Provide strategic guidance on CMC regulatory risks, change controls, health authority interactions, and submission strategies to support program objectives and regulatory compliance

• Coordinate and review responses to CMC-related health authority requests and ensure regulatory conformance of technical documentation, manufacturing information, validation activities, and labeling content

• Mentor and coach junior team members and provide oversight for vendors and/or assigned staff, including prioritization, feedback, and support for development activities

• Apply AI-enabled tools and digital technologies to improve the efficiency, quality, and consistency of regulatory deliverables while adhering to company policies and data governance standards

• Contribute to global regulatory activities, including demonstrated experience supporting Rest of World (ROW) submissions (e.g., MENA, LATAM, APAC) and coordinating regional filing requirements and strategies

Where You'll Work

 This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

• BA/BS degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or related scientific discipline required; advanced degree preferred

• Extensive Regulatory Affairs CMC experience within the biotechnology and/or pharmaceutical industry, including successful support of NDA/MAA submissions for new chemical entities in pre- and post-approval environments

• Demonstrated experience leading complex global regulatory submissions, including Rest of World (ROW) regions (e.g., MENA, LATAM, APAC), with ability to navigate regional regulatory requirements and coordinate cross-regional filing strategies

• Strong knowledge of global health authority regulations, CMC development, manufacturing processes, and Quality documentation standards, with the ability to apply regulatory strategy in complex development environments

• Proven ability to lead through influence in a matrixed organization, including strong cross-functional collaboration, strategic thinking, project management, communication, and problem-solving skills

• Demonstrated experience mentoring, coaching, and developing others; prior direct people management experience preferred but not required

• Demonstrated experience utilizing AI-enabled or digital tools to improve efficiency, quality, or decision-making in regulatory or technical workflows while maintaining compliance with company policies and data governance standards

• Ability to travel as needed (approximately 10–20%) to support business and regulatory activities