Senior Regulatory Affairs Consultant, CMC – Post-Approval Vaccines

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®.

We are seeking an experienced CMC regulatory professional to join our team as a Senior Regulatory Affairs Consultant, supporting post-approval vaccine products to join our team in remote capacity. As a Senior Regulatory Affairs Consultant, you will provide strategic leadership for the chemistry, manufacturing, and controls aspects of late-stage and marketed products. This position plays a key role in regulatory strategy, health authority engagement, submission quality, and manufacturing change management.

You’ll collaborate with senior leaders across R&D, Manufacturing, Quality Assurance, and Clinical Development, and shape CMC strategy from product development through registration and lifecycle management. Responsibilities include developing and overseeing CMC strategies for complex regulatory submissions and leading interactions with health authorities, with opportunities to deepen your expertise and influence program outcomes.

You’ll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic regulatory CMC leadership, health authority engagement, and high-quality regulatory submissions. With diverse teams and continuous learning opportunities, you’ll have the opportunity to explore career paths and expand skills across regulatory affairs and pharmaceutical development.

• 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,…