Regulatory Affairs Associate Director, CMC

Job description

Job Description Summary #LI-Hybrid Location: Basel, Switzerland We are looking for a Regulatory Affairs Associate Director, CMC to contribute to the development and delivery of global Chemistry, Manufacturing and Controls (CMC) regulatory strategies across a portfolio of products. In this role, you will support regulatory activities across development and lifecycle stages, ensuring high-quality submission content and alignment with global regulatory requirements. Working closely with cross-functional partners, you will help enable timely approvals and maintain compliant, consistent product information across markets. Job Description: Major Accountabilities: Contribute to the development and implementation of global CMC regulatory strategies for assigned projects and products. Plan, coordinate, and support CMC submission activities, including authoring, review, and submission of documentation. Identify documentation requirements and manage alignment on content, quality, and timelines across stakeholders. Author and review high-quality CMC regulatory documentation, ensuring compliance with applicable guidelines and standards. Communicate regulatory considerations, risks, and updates...