Director, Regulatory Affairs, CMC

Summit Therapeutics, Inc.

. Develop and execute CMC regulatory strategies for clinical and commercial development and lifecycle management .

Posted 10/21/2026full-timeRemote • United StatesLead💰 $190,000 - $237,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in developing and executing CMC regulatory strategies, managing high-quality global regulatory submissions, and engaging with health authorities. Proficient in interpreting global CMC regulations and maintaining compliance while fostering collaboration across cross-functional teams.

Highest-signal resume keywords

Regulatory CMC ExperienceBiologics KnowledgeFDA Regulations ExpertiseIND, CTA, BLA, MAA ProcessesProficiency in Mandarin Chinese

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Regulatory Strategy DevelopmentRegulatory Submission PreparationRisk AssessmentRegulatory Compliance ReviewHealth Authority InteractionProcess Improvement IdentificationDocument Management Systems ProficiencyDatabase SkillsAttention to DetailCritical Thinking

Soft Skills

Clear CommunicationOrganizational SkillsProblem SolvingTime ManagementAbility to Multitask

Tools & Technologies

Microsoft Office SuiteElectronic Document Management SystemsDocument Review Tools

Industry Keywords

Pharmaceutical IndustryGlobal CMC RegulationsHealth Authority MeetingsRegulatory CMC SubmissionsLifecycle Management

About the role

Key responsibilities & impact

Develop and execute CMC regulatory strategies for clinical and commercial development and lifecycle management
Manage preparation of high-quality global Regulatory CMC submissions, including IND, IMPD, BLA, MAA, and post-approval supplements
Represent Regulatory CMC on project teams and provide strategic regulatory input
Collaborate with CMC, Supply Chain, Quality, and Regulatory Affairs teams to implement regulatory strategies
Plan and participate in Health Authority meeting requests, briefing books, and responses to information requests
Review CMC sections of regulatory submissions for compliance and strategic alignment
Lead and participate in regulatory interactions with Health Authorities
Develop Regulatory CMC strategies and risk assessments for assigned projects
Identify continuous process improvements and engage relevant teams and stakeholders
Interpret global CMC regulations and guidelines for Summit personnel
Support Health Authority inspections
Escalate regulatory compliance issues to CMC RA Management
Maintain current knowledge of global CMC regulations and guidance

Requirements

What you’ll need

Bachelor’s degree in chemistry, pharmacy, engineering, biochemistry or related science required
10 or more years Regulatory CMC experience and/or related Pharmaceutical industry experience required
Experience in biologics required
Thorough and extensive knowledge of FDA, EU and global regulations required
Significant experience developing regulatory strategy for complex products
Experience preparing CMC sections for complex regulatory submissions
Excellent understanding of IND, CTA, BLA and MAA processes
Experience engaging with health authorities on regulatory CMC topics
Proficiency in Mandarin Chinese (spoken and written) highly desirable
Proficiency with Microsoft Office Suite, electronic document management systems, and document review tools desirable
Strong computer and database skills
Attention to detail, accuracy and confidentiality
Clear and concise oral and written communication skills
Excellent organizational skills
Critical thinking, problem solving, and ability to work independently
Ability to multitask and manage time-sensitive, highly confidential documents
Ability to communicate complex ideas clearly
Ability to prioritize conflicting demands
Ability to work in a fast-paced, demanding, and collaborative environment

Benefits

Comp & perks

Total compensation package may include bonus, stock, benefits and/or other applicable variable compensation
Equal Opportunity Employer commitment and non-discrimination in recruitment, hiring, training, and promotion