Senior Director, Regulatory CMC

Role Summary

The Senior Director, Regulatory CMC will lead and evolve Apellis’s global Chemistry, Manufacturing, and Controls (CMC) and Regulatory Device strategies to support the company’s innovative therapeutic pipeline and marketed products. This position is responsible for developing, executing, and maintaining high-impact CMC regulatory strategies across development and commercial stages, ensuring global compliance while driving innovation and operational efficiency. The role will oversee both Regulatory CMC and Regulatory Device functions, serving as a key cross-functional leader who leverages data-driven systems, AI-enabled document management, and digital regulatory tools to enhance submission quality, accelerate timelines, and ensure inspection readiness.

Responsibilities

• Lead global CMC and device regulatory strategies from development through commercialization, ensuring alignment with business goals and global regulatory expectations.
• Create and implement a long-term CMC regulatory plan that aligns with Apellis‚Äôs product pipeline strategy, supporting both short-term milestones and long-range business objectives.
• Partner with Technical Operations, Quality, and Device Engineering to define robust CMC strategies supporting INDs, CTAs, NDAs/BLAs, MAAs, and lifecycle management submissions.
• Oversee regulatory risk assessments and proactively identify and mitigate potential CMC or device-related regulatory hurdles.
• Champion innovation in regulatory processes, integrating digital transformation initiatives and AI-based systems for predictive compliance and submission optimization.
• Provide line management and leadership to direct reports, including employees and contractors, ensuring clarity of roles, accountability, and opportunities for professional development.
• Oversee budget planning and resource allocation for Regulatory CMC and Device functions, ensuring alignment with organizational priorities and efficient use of resources.

Regulatory Execution

• Direct and oversee the preparation, review, and submission of high-quality global CMC and device-related regulatory filings (INDs, IMPDs, CTAs, NDAs/BLAs, MAAs, variations, supplements, and responses to health authority inquiries).
• Ensure consistency, scientific integrity, and accuracy across all submissions through effective governance and collaboration with cross-functional contributors.
• Lead regulatory CMC interactions and negotiations with FDA, EMA, and other global agencies, effectively representing Apellis in technical and strategic discussions.
• Manage post-approval changes globally in accordance with emerging regulatory frameworks, ensuring timely compliance and lifecycle management.

Operational Excellence

• Build and mentor a high-performing team of Regulatory CMC and Device professionals, fostering an inclusive, agile, and innovative culture.
• Develop and maintain regulatory processes and tools leveraging AI-assisted content management, structured data submissions (e.g., eCTD, IDMP, PQ/CMC), and next-generation regulatory intelligence platforms.
• Collaborate with Regulatory Operations, IT, and Quality teams to integrate digital solutions for regulatory document tracking, real-time submission status visualization, and compliance analytics.
• Establish and maintain KPIs and dashboards to monitor submission performance, regulatory commitments, and agency interactions.

Cross-functional Collaboration

• Serve as the senior regulatory liaison for CMC and device topics within global project teams and governance committees.
• Partner with internal stakeholders to ensure regulatory considerations are embedded in product development, manufacturing strategy, and change control.
• Support due diligence, licensing, and partnership activities by providing expert regulatory CMC and device assessments.

Education, Registration & Certification

• Advanced degree (Ph.D., Pharm.D., M.S.) in a relevant scientific discipline (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering) preferred; Bachelor‚Äôs degree with exceptional experience will be considered.

Experience

• Minimum of 15 years of experience in Regulatory Affairs within the biopharmaceutical industry, including 8+ years of direct CMC regulatory experience and 5+ years in a leadership role.
• Proven track record of leading global CMC submissions and successful interactions with regulatory authorities (FDA, EMA, PMDA, Health Canada, etc.).

Skills

• Technical Expertise
  • Deep understanding of global CMC and device regulatory frameworks, including ICH guidelines, FDA/EMA CMC requirements, and post-approval change management.
  • Strong grasp of analytical methods, process development, validation, and manufacturing principles relevant to biologics and small molecules.
  • Familiarity with regulatory technology systems such as Veeva Vault RIM, IDMP data governance, and structured content authoring tools.
• Leadership and Communication
  • Exceptional leadership and people development skills; ability to manage, mentor, coach, and build high-performing global teams.
  • Strong communication and negotiation skills with a proven ability to represent the company effectively to global health authorities.
  • Strategic and analytical mindset with the ability to balance innovation, risk, and compliance.
• Innovation and Digital Agility
  • Demonstrated experience applying AI, machine learning, or automation tools to regulatory processes (e.g., submission readiness, document QC, regulatory intelligence) is an advantage.
  • Proficiency with core Microsoft Office tools, data visualization tools, and digital collaboration platforms.
  • Adaptable and forward-thinking, with a commitment to continuous improvement and operational excellence.

Travel

• Up to 20% travel expected.