Regulatory Affairs Associate Director, CMC

Major Accountabilities

• Contribute to the development and implementation of global CMC regulatory strategies for assigned projects and products.
• Plan, coordinate, and support CMC submission activities, including authoring, review, and submission of documentation.
• Identify documentation requirements and manage alignment on content, quality, and timelines across stakeholders.
• Author and review high-quality CMC regulatory documentation, ensuring compliance with applicable guidelines and standards.
• Communicate regulatory considerations, risks, and updates to cross-functional project teams and stakeholders.
• Contribute to and support Health Authority interactions, including preparation of briefing materials and responses.
• Collaborate across functions to support consistent delivery and alignment on regulatory activities.
• Contribute to continuous improvement initiatives and support knowledge sharing within the regulatory community.

Essential Requirements

• Fluency in English (written and spoken).
• Degree in a scientific discipline (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent experience.
• Demonstrated capability in CMC Regulatory Affairs, including regulatory submission and approval processes.
• Strong understanding of CMC regulatory requirements, with the ability to navigate complex regulatory topics and contribute to regulatory strategy.
• Ability to evaluate scientific data across multiple disciplines and translate insights into regulatory decision-making and documentation.
• Working knowledge of pharmaceutical development, manufacturing, or related scientific areas.
• Ability to collaborate effectively and influence within cross-functional, global matrix teams while managing multiple priorities.
• Strong planning, organisational, and interpersonal skills, with a focus on quality, delivery, and continuous improvement.