Director, Regulatory Affairs CMC

OverviewA Director, Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) Strategy is a leadership role within Regulatory Affairs responsible for the global regulatory strategy and execution related to the pharmaceutical quality and manufacturing of drug products. Responsibilities Strategic Leadership:Develop and execute global CMC regulatory strategies for products ranging from early-stage clinical development to post-approval lifecycle management. Regulatory Submissions:Oversee the preparation and high-quality review of CMC components for major filings, including INDs/CTAs, NDAs/BLAs/MAAs, and post-approval supplements.  Ensure CMC components in regulatory filings are scientifically sound, compliant, and aligned with ICH, FDA, EMA, and other global guidelines. Health Authority Interactions:Serve as the primary point of contact for CMC-related negotiations with regulatory agencies, including leading formal meetings and responding to deficiency letters. Cross-Functional Collaboration: Partner with Quality Assurance, CMC and Clinical Supply, R&D to ensure compliance with cGMP (current Good Manufacturing Practices) and assess the regulatory impact of CMC development plans and manufacturing changes. Intelligence & Compliance:Monitor the evolving global regulatory landscape and communicate the impact of new guidelines (e.g., ICH guidelines) to senior leadership. Team Mentorship:Lead, mentor, and develop a team of regulatory professionals, managing resources and project prioritization, as applicable. Supervision Exercised: May be required to mentor and provide guidance to junior team members. Qualifications A bachelor’s degree in a scientific field (Chemistry, Pharmacy, Biology, or Engineering) is required; an advanced degree (MS, PhD, or PharmD) is highly preferred. Requires 10–15+ yearsin the pharmaceutical industry, with at least 8–10 years specifically focused on CMC regulatory affairs Deep expertise in eCTDsubmission formats, global regulatory requirements (US, EU, and Canada), and a proven track record of successful marketing application approvals. Strong negotiation, conflict management, and the ability to influence cross-functional teams without direct authority. Expertise with multiple dosage forms for small molecule drugs is preferred Experience with biologics is a plus. Ability to travel up to 20% of the time domestically and internationally Experience working with Veeva

Created: 2026-03-04