Senior Regulatory Affairs Consultant, CMC - Post-Approval Vaccines

About the Role: 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.

Key Responsibilities: 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 managementDevelop 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 questionsAuthor 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 inputLead 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 stakeholdersDevelop strategies for addressing complex regulatory questions and issues, and address complex reviewer comments and manage sensitive regulatory correspondenceOversee 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 changesRepresent Regulatory CMC at high-level project team meetings and governance committees, and lead critical submission preparation meetings and regulatory strategy discussionsWork closely with senior leaders across R&D, Manufacturing, Quality Assurance, and Clinical Development, and facilitate effective communication between internal teams, external partners, and regulatory authoritiesProvide 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 managementMentor and develop team members in Regulatory CMC practices and strategic thinkingStay 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 initiativesCandidate Profile You'll thrive in this role if you bring: Strengths in CMC regulatory strategy, complex regulatory submissions, and health authority interactionsExperience working in a regulated pharmaceutical environment, with a focus on CMC for late-stage and marketed productsThe ability to collaborate across senior leadership teams, influence cross-functional stakeholders, and communicate clearly at every level A patient-focused mindset, strong attention to detail, and a big-picture perspectiveComfort working with global regulatory submission processes, health authority expectations, and quality systemsRequired QualificationsAdvanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related fieldMinimum of 10+ years of experience in Regulatory Affairs, with a strong focus on CMC for late-stage and marketed productsExtensive knowledge of global CMC regulatory requirements, submission processes, and health authority expectations, along with a deep understanding of pharmaceutical development, manufacturing processes, and quality systemsProven track record of successful regulatory submissions and positive health authority interactionsStrong analytical, communication, organization, and problem-solving skills, with excellent project management and the ability to influence and lead at senior levelsPreferred QualificationsPh. D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related fieldExperience with both small molecules and biologicsExperience with a regulatory agency, such as the FDA or MHRABenefits and CompensationHealth, Vision & Dental InsuranceTuition ReimbursementVacation/Holiday/Sick TimeFlexible Spending & Health Savings AccountsWork/Life Balance 401(k) with Company matchPet InsuranceFor a complete list of benefits, please visit www.parexel.com/us-benefits. Parexel offers competitive salaries based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location. Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions. If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply! We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research. #LI-LB1 #LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.