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