Regulatory Affairs Cmc Associate Director

Overview

• Serve as the Regulatory CMC Lead for late-stage small molecule development programs, ensuring compliance with global standards.
• Collaborate with cross-functional teams to shape CMC strategies and support product lifecycle management.
• Prepare, review, and submit high-quality CMC sections for regulatory submissions, including INDs, NDAs, and amendments.
• Develop and implement CMC risk management assessments and contingency plans for major submissions.
• Lead preparation of responses to Health Authority queries and develop strategies for regulatory meetings.
• Monitor global developments in CMC regulations, guidelines, and industry trends to evaluate their impact.
• Contribute to continuous improvement and establish best practices based on emerging industry trends.
• Foster relationships and communicate proactively with stakeholders to ensure alignment with program goals.

Key Responsibilities & Duties

• Lead regulatory CMC strategy and execution for assigned development programs, ensuring compliance with Health Authority requirements.
• Collaborate with technical and regulatory teams to support product development and commercialization efforts.
• Oversee preparation and submission of CMC sections for investigational and registration submissions.
• Prepare CMC Risk Management Assessments and escalate issues to management as needed.
• Develop strategies for Health Authority meetings, including preparation of meeting information packages.
• Monitor and evaluate global developments in CMC regulations and guidelines.
• Implement best practices and contribute to continuous improvement initiatives.
• Provide regulatory and scientific expertise to shape CMC strategies for development programs.

Job Requirements

• Bachelor of Science in a scientific discipline; post-graduate degree preferred.
• 7+ years of experience in the pharmaceutical/biopharmaceutical industry, including direct drug development experience.
• 3+ years of direct experience in Regulatory Affairs CMC, including leadership roles.
• In-depth understanding of Health Authority regulations, guidelines, and regulatory trends.
• Proven ability to lead global regulatory CMC strategies across different stages of product development.
• Advanced writing skills for delivering high-quality regulatory documents.
• Strong oral communication skills and ability to influence decisions effectively.
• Commitment to continuous improvement and ability to manage multiple priorities.