Senior Director, Regulatory CMC

🕒 September 10

🇺🇸 United States – Remote

💵 $203k - $253k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 16%

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2003

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of innovative medicinal therapies aimed at improving quality of life for oncology patients. The company is particularly committed to addressing serious unmet medical needs through its lead investigational therapy, ivonescimab, a novel bispecific antibody designed to target both PD-1 and VEGF. Summit’s initiatives include ongoing Phase III clinical trials to evaluate ivonescimab's effectiveness in treating non-small cell lung cancer, highlighting their dedication to patient-centered care and technological advancement in the field of oncology.

📋 Description

• Provide strategic leadership and oversight for global CMC regulatory activities across assigned programs and the broader portfolio • Define and execute global CMC regulatory strategy to support clinical development, licensure, and lifecycle management of biologic products • Represent Regulatory CMC at senior project team and governance levels • Lead cross-functional collaboration with CMC, Supply Chain, Quality, and Regulatory Affairs to develop and align global regulatory strategies and submission plans • Oversee planning, development, and finalization of high-quality CMC regulatory documents • Provide executive oversight of internal CMC submission review and approval processes • Lead regulatory CMC activities related to Health Authority interactions, including meeting strategy, briefing document oversight, and responses to information requests • Assess regulatory impact of CMC changes, deviations, and lifecycle management activities; direct associated regulatory submissions • Oversee timelines, resource planning, and prioritization of regulatory CMC activities • Serve as a subject matter expert on global CMC regulations and guidance • Lead continuous improvement initiatives for Regulatory CMC processes, systems, and cross-functional effectiveness • Escalate significant regulatory risks or compliance issues to senior leadership with recommendations for resolution • Monitor global CMC regulatory trends, emerging guidance, and Health Authority expectations • Mentor, develop, and provide leadership to Regulatory CMC staff

🎯 Requirements

• Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biochemistry, or related scientific discipline required; advanced degree (Master’s or PhD) strongly preferred • 10 or more years of Regulatory CMC experience and/or related pharmaceutical/biotechnology industry experience required, with demonstrated leadership responsibility • Significant experience with biologic products across clinical development and commercialization required • Deep and comprehensive knowledge of FDA, EU, and other global CMC regulatory requirements and expectations • Extensive experience leading preparation and review of CMC sections for global regulatory submissions (IND, IMPD/CTA, BLA, MAA, variations, supplements, amendments) • Strong understanding of global development and registration processes including IND, CTA, BLA, and MAA pathways • Prior experience serving as a regulatory CMC lead in Health Authority interactions • Proficiency in Mandarin Chinese (spoken and written) is highly desirable • Proficient with Microsoft Office applications (Word, Excel) and experienced with electronic document management and regulatory publishing systems • Strong analytical, problem-solving, and strategic thinking skills • Excellent written and verbal communication skills • Demonstrated ability to lead, influence, and collaborate across functions at both operational and senior leadership levels • Exceptional organizational skills with the ability to manage multiple, time-sensitive priorities • Proven ability to work effectively in a fast-paced, demanding, and highly collaborative environment while maintaining attention to detail, confidentiality, and regulatory compliance

🏖️ Benefits

• Bonus, stock, benefits and/or other applicable variable compensation may be included in the total compensation package • Equal Opportunity Employer

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