Director of Regulatory CMC

At Indegene, we are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To lead, build CMC expertise, and oversee a growing CMC writing team within our Regulatory Services business. This leader will be responsible for both internal team management and client-facing strategic CMC consulting. The ideal candidate brings hands-on CMC expertise, including preparation of CMC documentation, as well as confidence, poise, and the ability to lead client engagements. This role will also help shape best practices for CMC content generated via our AI platform, collaborating closely with clients and internal teams as we advance our CMC capabilities. Responsibilities: Leadership and Team Building: Lead, mentor, and expand a global team of CMC medical writers/experts. Establish team structure, processes, and operational standards for a newly built CMC capability. Contribute to the development of CMC operating models, processes, and procedural documentation. • Client-Facing Responsibilities: Represent the CMC team as a senior subject matter expert in meetings with clients, including regulatory strategy discussions and project scoping. Provide expert input into solutions