Head of Regulatory CMC in Massachusetts

Position Title:

Head of Regulatory CMC

Company Overview:

Stirling Q&R is seeking a dynamic and experienced Head of Regulatory CMC (Chemistry, Manufacturing, and Controls) to lead our regulatory efforts in ensuring compliance with CMC requirements for our pharmaceutical and biotech products. This strategic role will play a key part in bridging the gap between manufacturing and regulatory affairs.

Key Responsibilities:

• Lead the development and execution of regulatory CMC strategies that align with product development timelines and company objectives.
• Oversee the preparation and submission of CMC documentation to regulatory agencies, ensuring compliance with global regulations.
• Collaborate closely with R&D, Quality Assurance, and Manufacturing teams to ensure that all aspects of CMC are addressed in regulatory submissions.
• Act as the primary point of contact for regulatory authorities during CMC-related...