Director, Regulatory Affairs CMC

A 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.

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.

• 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