Associate Director/Director, CMC Regulatory

As part of the Pharmaceutical Development team, this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.   

Your Role: 

• With minimal supervision, accountable for developing and leading the execution of regulatory CMC investigational, registration and/or post-approval strategies for Relay's development programs/products.
• Develop and execute CMC global submission plans and timelines in accordance with project goals
• Strong and deep foundational understanding of global RA CMC regulations and guidelines.
• Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance.
• Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations.  Strong analytical or process understanding that enables the development of robust and accurate submissions.
• Apply global regulatory CMC knowledge to address and overcome challenges that arise during development and commercialization.
• Responsible for leading and coordination of responses to CMC questions/RFIs from regulatory authorities in conjunction with CMC and regulatory affairs leads/SMEs.