Regulatory Affairs CMC – Manager/Associate Director/Director
hace 3 semanas
Regulatory Affairs CMC – Manager/Associate Director/Director Position Summary We are seeking an experienced Regulatory Affairs CMC professional to support regulatory strategy and execution for small molecule development programs. The role will provide regulatory CMC leadership across the product lifecycle—from pre-IND through post-approval—ensuring high-quality CMC submissions and alignment with global health authority requirements. The level of the role (Manager, Associate Director, or Director) will be determined based on experience and demonstrated expertise. Responsibilities Regulatory Strategy & Leadership Develop and execute global regulatory CMC strategies to support small molecule programs through all phases of development and commercialization. Serve as the primary CMC regulatory contact for internal teams and external partners, ensuring alignment of regulatory strategies with program objectives. Interpret and apply global CMC regulations, guidelines, and precedents to drug substance and drug product development. Engage with health authorities (FDA, EMA, PMDA, etc.) on CMC matters, including preparation of meeting briefing documents and leading discussions as appropriate. Submission Development & Lifecycle Management Author, review, and manage CMC sections of regulatory submissions, including INDs/CTAs, NDAs/MAAs, IMPDs, Annual Reports, and post-approval supplements/variations. Ensure accuracy, scientific integrity, and compliance with applicable regulations and company standards. Support change control assessments and contribute to regulatory impact analyses. Maintain oversight of submission timelines, proactively identifying risks and mitigation strategies. Cross-Functional Collaboration Partner with Technical Development, Manufacturing, Quality, and Project Management to ensure regulatory requirements are integrated into CMC development and lifecycle plans. Provide regulatory guidance on analytical methods, specifications, process validation, stability, and comparability assessments for small molecules. Contribute to CMC aspects of due diligence and business development activities, as needed. Qualifications & Experience Manager Level: Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or related field. 4–7 years of regulatory CMC or related CMC experience in the pharmaceutical industry. Experience with authoring Module 2 and Module 3 CMC sections of regulatory submissions for small molecules. 8–12 years of experience in regulatory CMC, including significant small molecule expertise. Demonstrated success leading CMC strategy for development programs through at least one major submission (IND/CTA, NDA/MAA). Experience interacting with global health authorities. 12+ years of regulatory CMC experience, with leadership across multiple development programs and approvals in small molecules. Deep understanding of global CMC regulatory frameworks, trends, and emerging requirements. Proven ability to influence regulatory outcomes through proactive engagement with health authorities. Seniority level Director Employment type Full-time Job function Manufacturing #J-18808-Ljbffr
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