About this role
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