Job Description

This role requires 3 days a week at the client office in Melbourne.

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Key Responsibilities:

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Strategic Leadership:

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- Provide strategic direction and oversight for CMC aspects of late-stage and marketed products
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- Deliver strategic input on critical cross-project topics, ensuring alignment with overall business objectives
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- Develop comprehensive CMC strategies to support product development, registration, and lifecycle management
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Regulatory Strategy and Submissions:

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- Develop and oversee CMC strategies for complex regulatory submissions, including:n n
- Investigational New Drug (IND) applications
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- Investigational Medicinal Product Dossiers (IMPDs)
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- Biologics License Applications (BLAs)
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- Marketing Authorization Applications (MAAs)
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- Post-approval variations/supplements
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- Responses to health authority questions
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- Author and review high-level regulatory submissions
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- Ensure all submissions conform to relevant health authority guidelines and regulations
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- Lead submission preparation meetings and coordinate cross-functional input
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Health Authority Interactions:

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- Lead regulatory CMC discussions and interactions with Health Authorities
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- Represent the company in high-level meetings with regulatory agencies
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- Develop strategies for addressing complex regulatory questions and issues
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- Build and maintain positive relationships with key regulatory stakeholders
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Regulatory Assessment and Change Management:

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- Oversee regulatory assessments of manufacturing changes
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- Establish data requirements and strategies for regulatory submissions related to manufacturing changes
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- Provide expert guidance on CMC-related regulatory implications of proposed changes
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Project Management and Leadership:

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- Represent Regulatory CMC at high-level project team meetings and governance committees
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- Lead critical submission preparation meetings and regulatory strategy discussions
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- Address complex reviewer comments and manage sensitive regulatory correspondence
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- Provide regular updates to senior management on project status, risks, and key milestones
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- Mentor and develop team members in Regulatory CMC practices and strategic thinking
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Cross-functional Collaboration:

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- Work closely with senior leaders across various departments, including R&D;, Manufacturing, Quality Assurance, and Clinical Development
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- Facilitate effective communication between internal teams, external partners, and regulatory authorities
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- Provide expert CMC regulatory guidance to support critical business decisions and product lifecycle management
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Regulatory Intelligence and Innovation:

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- Stay at the forefront of evolving CMC regulations, guidelines, and industry best practices
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- Drive the development and implementation of innovative CMC regulatory strategies
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- Participate in and potentially lead relevant industry groups and regulatory authority initiatives
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Qualifications:

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- Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering,



or a related field (Ph.D. preferred)
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- Minimum of 15+ years of experience in Regulatory Affairs, with a strong focus on CMC for late-stage and marketed products
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- Extensive knowledge of global CMC regulatory requirements, submission processes, and health authority expectations
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- Proven track record of successful regulatory submissions and positive health authority interactions
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- Deep understanding of pharmaceutical development, manufacturing processes, and quality systems
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- Experience with both small molecules and biologics is highly desirable
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- Excellent project management skills with the ability to oversee multiple complex projects simultaneously
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- Strong analytical and problem-solving skills
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- Outstanding written and verbal communication skills
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- Demonstrated ability to influence and lead at senior levels within an organization
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Desired Qualities:

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- Visionary leader with the ability to anticipate and navigate complex regulatory challenges
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- Strategic thinker with a talent for innovative problem-solving and risk management
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- Strong leadership skills with the ability to influence cross-functional teams and senior management
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- Proactive and self-motivated with a commitment to regulatory excellence
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- Adaptable to changing priorities and evolving regulatory landscapes
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- Excellent interpersonal skills with the ability to build robust relationships with internal and external stakeholders
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- Detail-oriented with a focus on quality and accuracy, while maintaining a big-picture perspective
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- Ability to thrive in a fast-paced environment and manage competing priorities
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#LI-REMOTE

📌 Regulatory Affairs Consultant - FSP (CMC) (Victoria)
🏢 Parexel International
📍 Victoria