Director/Sr. Director, Regulatory Affairs CMC (Head of Regulatory CMC, Small Molecule) - Remote

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Requirements:

• 12 years in CMC Global Regulatory Affairs strategy
• Excellent CMC technical writing and communications skills with a strong background in small molecules, ideally solid- oral dose formulations, manufacturing, and regulatory writing
• Experience with all phases of pharmaceutical development and related implementation of phase-appropriate regulatory CMC requirements and strategies
• Demonstrated success driving drug product development and managing all aspects of CMC documentation
• Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and other global regulations
• Fluency with eCTD structure, differences in regional dossier requirements, and software tools commonly used to author, review, format, and approve submission documents

Responsibilities:

• Develop a comprehensive CMC regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, and effective regulatory agency interactions to support planned filings
• Lead and manage the development and preparation of high-quality global submissions (including IMPDs and M3 for IND, NDAs, and MAAs) for early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval, as applicable
• Support communication with global Health Authorities (HA), such as FDA and EMA, including, planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.