Senior RA CMC Leader: Regulatory Strategy & Submissions

The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) leads initiatives to develop and manage regulatory strategies for CMC submissions, including INDs/CTAs and amendments. This role builds relationships across Regulatory Affairs, Operations and R&D to drive first-pass approvals and prepares content for agency submissions.

The candidate will serve as strategic liaison with regulatory authorities, negotiate and influence teams to maximize chances of successful