Regulatory Affairs Consultant - FSP (CMC)

Job description

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