Director, CMC Regulatory

🕒 April 10

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Sabin Vaccine Institute

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1993

⚕️ Healthcare Insurance

🧬 Biotechnology

🤝 Non-profit

💰 $35M Grant on 2023-01

Healthcare Insurance • Biotechnology • Non-profit

Sabin Vaccine Institute is dedicated to improving global health by ensuring access to life-saving vaccines. The institute focuses on research and development of new vaccines for some of the world’s most pressing diseases, including cholera, HPV, malaria, Marburg, and Ebola. Through innovative programs and partnerships, Sabin aims to enhance immunization capacities and vaccine acceptance within communities, ultimately striving to make vaccination accessible to all, especially vulnerable populations.

📋 Description

• Provide strategic leadership and hands-on subject-matter expertise to enable end-to-end vaccine development • Lead planning, development, and delivery of high-quality CMC content and documentation • Collaborate with CMC, Quality Assurance, manufacturing/CMOs, and other cross-functional stakeholders • Author and critically review CMC sections of U.S. FDA submissions and lifecycle updates • Drive CMC regulatory support for global development and access • Coordinate responses to CMC information requests from U.S. FDA and/or other regulatory agencies • Maintain a strong global regulatory intelligence posture • Support engagement and negotiation with regulators to resolve key CMC issues

🎯 Requirements

• 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 • Ability to manage complex tasks, prioritize competing objectives, and work well under pressure, maintaining clear purpose and attention to detail • Proficient in Microsoft Office applications (Excel, Outlook, PowerPoint, Word), and Adobe Acrobat.

🏖️ Benefits

• Medical coverage • Dental coverage • Vision coverage • Flexible spending accounts • Flexible vacation leave • Sick leave • Short-term disability options • Long-term disability options • 10 federal holidays • End of the year winter break • Employer matching 401(k) plan