Associate Director, Regulatory Starting Material

For our client, we are seeking a Associate Director, Regulatory Starting Material to join the team of a leader in the Pharmaceuticals & Biotech space. This role will shape strategy for regulatory starting materials across late-stage development and commercial programs, with a strong focus on CMC rigor and health authority readiness. The position will partner closely with process chemistry, analytical, and regulatory stakeholders to ensure starting material decisions are scientifically sound and well supported in global submissions. It will also help guide resupply and scale-up activities while balancing technical, operational, and compliance considerations in a highly regulated environment. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $126,000 – $268,400 annually Responsibilities Lead strategy for regulatory starting materials based on ICH Q11 Manage starting material resupply and scale-up campaigns Author CMC regulatory submission content for INDs, NDAs, and MAAs Prepare and lead interactions with health authorities regarding starting materials Collaborate with process chemistry and analytical teams to assess starting material relevance Qualifications Advanced degree in chemistry, chemical engineering, or a related field; PhD strongly preferred 7+ years of experience in CMC, process chemistry, or drug substance/API development Proven track record supporting late-stage clinical and commercial drug substance programs In-depth knowledge of ICH Q11 and regional guidance on regulatory starting materials Experience with CMC regulatory submissions and health authority interactions Benefits Opportunity for flexible spending accounts Comprehensive medical, dental, and vision benefits 401(k) and pension plan participation Generous vacation and leave policies Employee assistance and well-being programs Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.