Regulatory Affairs Cmc Associate Director

Overview

• Drive regulatory CMC strategies for innovative pharmaceutical products, ensuring global compliance and supporting lifecycle management.
• Collaborate with cross-functional teams to shape development strategies and achieve program goals.
• Prepare, review, and submit comprehensive CMC documentation for regulatory submissions, including INDs and NDAs.
• Develop risk management plans and contingency strategies to address regulatory challenges effectively.
• Lead responses to Health Authority queries and prepare for regulatory meetings.
• Stay updated on global CMC regulations and trends to enhance compliance strategies.
• Contribute to process improvements and establish best practices within the organization.
• Foster strong relationships with stakeholders to align regulatory strategies with organizational objectives.

Key Responsibilities & Duties

• Lead the development and execution of regulatory CMC strategies for assigned programs.
• Collaborate with technical teams to support product development and commercialization efforts.
• Prepare and submit high-quality CMC sections for regulatory filings, ensuring accuracy and compliance.
• Develop risk assessments and escalate critical issues to management promptly.
• Strategize and prepare for Health Authority meetings, including compiling meeting materials.
• Monitor changes in global CMC regulations and provide insights to the organization.
• Implement best practices and contribute to continuous improvement initiatives within the regulatory framework.
• Provide scientific and regulatory expertise to shape development strategies effectively.

Job Requirements

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Minimum of 7 years of experience in the pharmaceutical or biopharmaceutical industry.
• At least 3 years of direct experience in Regulatory Affairs CMC roles.
• Strong understanding of Health Authority regulations and global compliance requirements.
• Proven leadership in developing and executing regulatory CMC strategies.
• Excellent written and verbal communication skills for regulatory documentation and stakeholder engagement.
• Ability to manage multiple priorities and deliver results in a dynamic environment.
• Commitment to continuous learning and improvement in regulatory practices.