Senior Regulatory Affairs Associate (CMC)

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Solid experience in global CMC regulatory from local/ global pharma or relevant experience Expertise in global CMC regulatory requirements for post-marketing variations With strong experience in biologicals (vaccines preferred) for EU and US FDA. We are seeking an experienced Senior Associate level of Regulatory CMC to join our team. In this role, you will be responsible for developing CMC strategies and managing regulatory submissions for both early-stage programs and marketed products. The ideal candidate will have extensive experience in authoring and reviewing regulatory submissions, performing regulatory assessments of manufacturing changes, and representing Regulatory CMC in cross-functional teams. Key Responsibilities: Regulatory Strategy and Submissions: - Develop comprehensive CMC strategies for early-stage programs and marketed products - Author and review regulatory submissions, including: • Investigational New Drug (IND) applications • Investigational Medicinal Product Dossiers (IMPDs) • Post-approval variations/supplements • Annual reports • Responses to health authority questions - Ensure all submissions conform to relevant health authority guidelines and regulations - Lead submission preparation meetings and coordinate cross-functional input Regulatory Assessment and Change Management: - Perform regulatory assessments of manufacturing changes - Establish data requirements for regulatory submissions related to manufacturing changes - Provide expert guidance on CMC-related regulatory implications of proposed changes Project Management and Leadership: - Represent Regulatory CMC at project team meetings - Lead submission preparation meetings - Address reviewer comments and manage regulatory correspondence - Provide regular updates to Management on project status and key milestones - Mentor junior team members in Regulatory CMC practices Cross-functional Collaboration: - Work closely with various departments, including R&D, Manufacturing, Quality Assurance, and Clinical Development - Facilitate effective communication between internal teams and regulatory authorities - Provide CMC regulatory expertise to support business decisions and product development strategies Regulatory Intelligence: - Stay current with evolving CMC regulations, guidelines, and industry best practices - Contribute to the development and implementation of internal CMC regulatory policies and procedures - Participate in relevant industry groups and regulatory authority meetings as needed Qualifications: - Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field (Ph.D. preferred) - Minimum of 8+ years of experience in Regulatory Affairs, with a strong focus on CMC - Extensive knowledge of global CMC regulatory requirements and submission processes - Proven track record of successful regulatory submissions and interactions with health authorities - Strong understanding of pharmaceutical development, manufacturing processes, and quality systems - Experience with both small molecules and biologics is highly desirable - Excellent project management skills with the ability to manage multiple projects simultaneously - Strong analytical and problem-solving skills - Outstanding written and verbal communication skills Desired Qualities: - Strategic thinker with the ability to anticipate and address potential regulatory challenges - Strong leadership skills with the ability to influence cross-functional teams - Proactive and self-motivated with a commitment to excellence - Adaptable to changing priorities and evolving regulatory landscapes - Excellent interpersonal skills with the ability to build strong relationships with internal and external stakeholders - Detail-oriented with a focus on quality and accuracy If you are an experienced Regulatory CMC professional with a passion for developing and implementing effective regulatory strategies, we invite you to apply for this key role in our organization. Join us in ensuring the successful development and commercialization of our products through expert regulatory guidance and leadership. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.