Apellis Pharmaceuticals · 2 months ago
Senior Director, Regulatory CMC
Waltham, Massachusetts, United States
Full-time
Onsite
Director/Executive
$239K/yr - $358K/yr
15+ years expApellis is a global biopharmaceutical company focused on developing innovative therapies for challenging diseases. The Senior Director, Regulatory CMC will lead the global Chemistry, Manufacturing, and Controls strategies to ensure compliance and operational efficiency while overseeing regulatory submissions and fostering cross-functional collaboration.
BiotechnologyHealth CarePharmaceuticalTherapeutics
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’s 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
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
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
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
Qualification
Required
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.)
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
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
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
Preferred
Advanced degree (Ph.D., Pharm.D., M.S.) in a relevant scientific discipline (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering) preferred; Bachelor's degree with exceptional experience will be considered
Demonstrated experience applying AI, machine learning, or automation tools to regulatory processes (e.g., submission readiness, document QC, regulatory intelligence) is an advantage
Benefits
401(k) plan with company match
Inclusive family building benefits
Flexible time off
Summer and winter shutdowns
Paid family leave
Disability and life insurance
Company
Apellis Pharmaceuticals
Apellis Pharmaceuticals focuses on developing novel therapeutics and drug delivery technologies to address chronic inflammatory diseases.
501-1000 employees
H1B Sponsorship
Apellis Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (6)
2023 (6)
2022 (8)
2021 (7)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$919.6MKey Investors
Swedish Orphan BiovitrumSixth StreetNorthern Star Partners
2025-06-01Post Ipo Debt· $275M
2024-05-14Post Ipo Debt· $475M
2022-04-14Post Ipo Equity· $1.07M
Leadership Team
Cedric Francois
Co-Founder and CEO
Caroline Baumal
Chief Medical Officer
Recent News
2026-01-18
Investor's Business Daily
2026-01-13
Company data provided by crunchbase