Senior Regulatory Affairs Consultant, CMC – Post-Approval Vaccines

Required Qualifications

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field
• Minimum of 10+ years of experience in Regulatory Affairs, with a strong focus on CMC for late-stage and marketed products
• Extensive knowledge of global CMC regulatory requirements, submission processes, and health authority expectations, along with a deep understanding of pharmaceutical development, manufacturing processes, and quality systems
• Proven track record of successful regulatory submissions and positive health authority interactions
• Strong analytical, communication, organization, and problem-solving skills, with excellent project management and the ability to influence and lead at senior levels

• Provide strategic direction and oversight for CMC aspects of late-stage and marketed products, and develop comprehensive CMC strategies to support product development, registration, and lifecycle management
• Develop and oversee CMC strategies for complex regulatory submissions, including Investigational New Drug (IND) applications, Investigational Medicinal Product Dossiers (IMPDs), Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), post-approval variations and supplements, and responses to health authority questions
• Author and review high-level regulatory submissions, ensure all submissions conform to relevant health authority guidelines and regulations, and lead submission preparation meetings with coordinated cross-functional input
• Lead regulatory CMC discussions and interactions with Health Authorities, represent the company in high-level meetings with regulatory agencies, and build and maintain positive relationships with key regulatory stakeholders
• Develop strategies for addressing complex regulatory questions and issues, and address complex reviewer comments and manage sensitive regulatory correspondence
• Oversee regulatory assessments of manufacturing changes, establish data requirements and strategies for related regulatory submissions, and provide expert guidance on CMC-related regulatory implications of proposed changes
• Represent Regulatory CMC at high-level project team meetings and governance committees, and lead critical submission preparation meetings and regulatory strategy discussions
• Work closely with senior leaders across R&D, Manufacturing, Quality Assurance, and Clinical Development, and facilitate effective communication between internal teams, external partners, and regulatory authorities
• Provide regular updates to senior management on project status, risks, and key milestones, and provide expert CMC regulatory guidance to support critical business decisions and product lifecycle management
• Mentor and develop team members in Regulatory CMC practices and strategic thinking
• Stay at the forefront of evolving CMC regulations, guidelines, and industry best practices, drive the development and implementation of innovative CMC regulatory strategies, and participate in or potentially lead relevant industry groups and regulatory authority initiatives