Regulatory Affairs Consultant - Fsp

**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. This role requires 3 days a week at the client office in Melbourne. Key Responsibilities: Strategic Leadership: * Provide strategic direction and oversight for CMC aspects of late-stage and marketed products * Deliver strategic input on critical cross-project topics, ensuring alignment with overall business objectives * Develop comprehensive CMC strategies to support product development, registration, and lifecycle management Regulatory Strategy and Submissions: * 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/supplements * Responses to health authority questions * Author and review high-level regulatory submissions * Ensure all submissions conform to relevant health authority guidelines and regulations * Lead submission preparation meetings and coordinate cross-functional input Health Authority Interactions: * Lead regulatory CMC discussions and interactions with Health Authorities * Represent the company in high-level meetings with regulatory agencies * Develop strategies for addressing complex regulatory questions and issues * Build and maintain positive relationships with key regulatory stakeholders Regulatory Assessment and Change Management: * Oversee regulatory assessments of manufacturing changes * Establish data requirements and strategies 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 high-level project team meetings and governance committees * Lead critical submission preparation meetings and regulatory strategy discussions * Address complex reviewer comments and manage sensitive regulatory correspondence * Provide regular updates to senior management on project status, risks, and key milestones * Mentor and develop team members in Regulatory CMC practices and strategic thinking Cross-functional Collaboration: * Work closely with senior leaders across various departments, including R&D, Manufacturing, Quality Assurance, and Clinical Development * Facilitate effective communication between internal teams, external partners, and regulatory authorities * Provide expert CMC regulatory guidance to support critical business decisions and product lifecycle management Regulatory Intelligence and Innovation: * Stay at the forefront of evolving CMC regulations, guidelines, and industry best practices * Drive the development and implementation of innovative CMC regulatory strategies * Participate in and potentially lead relevant industry groups and regulatory authority initiatives Qualifications: * Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field (Ph.D. preferred) * Minimum of 15+ 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 * Proven track record of successful regulatory submissions and positive health authority interactions * Deep 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 oversee multiple complex projects simultaneously * Strong analytical and problem-solving skills * Outstanding written and verbal communication skills * Demonstrated ability to influence and lead at senior levels within an organization Desired Qualities: * Visionary leader with the ability to anticipate and navigate complex regulatory challenges * Strategic thinker with a talent for innovative problem-solving and risk management * Strong leadership skills with the ability to influence cross-functional teams and senior management * Proactive and self-motivated with a commitment to regulatory 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, while maintaining a big-picture perspective * Ability to thrive in a fast-paced environment and manage competing priorities