Director, CMC Regulatory

Reports to: Senior Director, Regulatory Affairs

Location: Remote Work, US Only

 

Why Sabin: 

Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management, and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.

Position Summary: 

The Director, CMC Regulatory reports to the Senior Director, Regulatory Affairs and will provide strategic leadership and hands-on subject-matter expertise to enable end-to-end vaccine development from early clinical through licensure and lifecycle management with primary accountability for U.S. regulatory CMC strategy and execution. This role leads the planning, development, and delivery of high-quality CMC content and documentation, partnering closely with CMC, Quality Assurance, manufacturing/CMOs, and other cross-functional stakeholders to ensure CMC requirements are anticipated, decisions are well-framed, and filings are submission-ready. The Director is the CMC regulatory SME with demonstrated experience authoring and critically reviewing CMC sections of U.S. FDA submissions and lifecycle updates, ensuring CMC documentation consistently meets applicable regulatory expectations and supports timely development, licensure, and post-approval change management.

In addition to U.S. leadership, the Director drives CMC regulatory support for global development and access, coordinating international regulatory strategies and deliverables for European, African, and other applicable regulators. The role collaborates with internal teams and external partners to plan, prepare, author, review, track, and archive submissions and responses for international authorities; supports engagement and negotiation with regulators to resolve key CMC issues and expedite clinical trial and marketing applications; and maintains a strong global regulatory intelligence posture by monitoring evolving international requirements and relevant guideline trends (including ICH alignment). This includes practical experience with U.S. and international applications ensuring CMC documentation, comparability rationale, and control strategies are globally coherent while remaining fit-for-purpose for regional submissions and registration needs.

Key Responsibilities:

• Work cross-functionally with CMC, Quality Assurance, and Regulatory to develop CMC regulatory strategies for the U.S. and international markets.
• Collaborate with CMC, QA, and Regulatory to plan, prepare, author, and review CMC-related submissions to INDs, DMFs, EUAs, BLAs, and other applications as needed.
• Identify the required documentation and address content, quality and/or timeline issues for U.S. and international submissions; coordinate timely delivery of approved technical source documents, in accordance with project timelines.
• Provide regulatory review and impact/implementation assessments of proposed Change Control records and manage the associated regulatory notifications.
• Lead regulatory risk assessments and develop mitigation strategies for CMC activities with potential regulatory or financial impact. 
• Proactively identify potential risks related to CMC regulatory strategy, through internal and external communications.
• Coordinate responses to CMC information requests from U.S. FDA and/or other regulatory agencies.
• Ensure appropriate document controls and archiving procedures, in accordance with regulatory standards and SOPs.
• Oversee CMC regulatory activities to ensure compliance with U.S., international, and regional regulations and applicable guidelines.
• Monitor and interpret global regulatory requirements and trends and communicate potential impact to key stakeholders.
• Contribute to regulatory intelligence activities, including monitoring new guidelines and providing interpretive guidance to internal teams.
• Support due diligence and regulatory assessments for potential partnerships, acquisitions, or in-licensing opportunities.

• Minimum bachelor’s degree in biochemistry, chemistry, biology, chemical engineering, or related pharmaceutical science required, advanced degree highly desired 
• 12+ years of experience in Regulatory Affairs or related role, preferably in biologics development.
• Proven track record in leading Regulatory CMC activities for regulatory filings in both pre- and post-approval settings.
• Experience in regulatory oversight of validation lifecycle activities, including process performance qualification (PPQ), continued process verification (CPV), and inclusion of validation data and information in marketing applications.
• Thorough knowledge of biologics development, cGMPs, regulatory submissions, FDA regulations, ICH guidance, and industry standards.
• Experience preparing regulatory submissions and briefing packages for regulatory meetings.
• Experience with Emergency Use Authorizations (EUAs) and/or BLAs is a plus.
• Excellent interpersonal, active listening, and influencing skills.
• Enthusiasm for problem solving, discovery, and knowledge enrichment.
• Ability to manage complex tasks, prioritize competing objectives, and work well under pressure, maintaining clear purpose and attention to detail.
• Team player with time-proven interpersonal skills, consistently showing respect and appreciation of co-workers and colleagues.
• Proficient in Microsoft Office applications (Excel, Outlook, PowerPoint, Word), and Adobe Acrobat.

Other: 

• Subject to a criminal background investigation 
• Request for three professional  references 
• Verification of  education/degrees

Sabin’s philosophy is to ensure fair, unbiased, equitable, competitive compensation and benefits. Using benchmarking and salary survey data, the annual salary for this position ranges from $180,000 - $205,000. The exact compensation may vary based on skills, experience, training, and certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs.

Sabin provides a comprehensive benefits package for eligible, featuring medical, dental, and vision coverage as well as flexible spending accounts. Eligible employees enjoy flexible vacation leave, sick leave, and both short-term and long-term disability options. The organization observes 10 federal holidays plus an end of the year winter break. Additionally, Sabin offers an employer matching 401(k) plan.

Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.