Associate Director, Global Regulatory, CMC

About the Role The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities across the product lifecycle, develop global CMC strategies, and guide product teams. The role includes preparing CMC and Quality related agency correspondence and regulatory applications, and managing multiple projects in a fast-paced environment to deliver transformative medicines to patients. What You'll Do

• Develop and implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks.
• Provide guidance for regulatory CMC aspects of product development projects.
• Review documents for submission-readiness to ensure that submissions conform to health authority guidelines.
• Lead Regulatory CMC discussions with cross-functional teams and stakeholders.
• Coordinate regulatory CMC activities throughout the product lifecycle and manage multiple projects.
• Prepare CMC and Quality related agency correspondence and regulatory applications. What We're Looking For
• Experience coordinating regulatory CMC activities for one or more products through all lifecycle stages.
• Ability to develop and implement global regulatory CMC strategies and collaborate with stakeholders.
• Experience preparing CMC and Quality related agency correspondence and regulatory applications.
• Strong project management skills to manage multiple projects in a fast-paced environment.
• Strong written and verbal communication skills with health authorities and internal teams.