Senior Director, Regulatory CMC
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Job Description
Senior Director leading global CMC regulatory strategy for Summit Therapeutics, a biopharmaceutical oncology company. Overseeing biologics submissions, Health Authority interactions, and lifecycle compliance.
Responsibilities:
- 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, providing strategic guidance to enable successful product development and approval.
- Lead cross-functional collaboration with CMC, Supply Chain, Quality, and Regulatory Affairs to develop and align global regulatory strategies and submission plans.
- Oversee the planning, development, and finalization of high-quality CMC regulatory documents to meet global regulatory requirements.
- Provide executive oversight of internal CMC submission review and approval processes to ensure compliance, quality, and alignment with company strategy.
- Lead regulatory CMC activities related to Health Authority interactions, including meeting strategy, briefing document oversight, and responses to information requests.
- Ensure proactive assessment of regulatory impact related to CMC changes, deviations, and lifecycle management activities; direct preparation of associated regulatory submissions.
- Oversee timelines, resource planning, and prioritization of regulatory CMC activities in alignment with corporate and development objectives.
- Serve as a subject matter expert on global CMC regulations and guidance, advising internal stakeholders on regulatory expectations and risk mitigation.
- Identify, lead, and implement continuous improvement initiatives to enhance Regulatory CMC processes, systems, and cross-functional effectiveness.
- Escalate significant regulatory risks or compliance issues to senior leadership and provide clear recommendations for resolution.
- Maintain current knowledge of global CMC regulatory trends, emerging guidance, and Health Authority expectations, and translate these into strategic insights for the organization.
- Mentor, develop, and provide leadership to Regulatory CMC staff, fostering a high-performing and collaborative team environment.
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.
- 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 with the ability to operate effectively in complex and ambiguous environments.
- Excellent written and verbal communication skills, with the ability to clearly articulate complex regulatory concepts to diverse audiences.
- 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
- Other applicable variable compensation
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