Senior Director, Regulatory CMC

The role

The Senior Director, Regulatory CMC develops regulatory strategies and submissions for Summit products globally. This role provides leadership for development, commercialization, and life cycle management of biologics.

What you will do

• Develop CMC regulatory strategies for biologics at all stages of development
• Provide high level strategic and operational regulatory direction on regulatory CMC issues globally
• Lead strategic regulatory development plans and risk assessments
• Lead CMC content authoring, review, and approval of regulatory submissions
• Lead regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness
• Serve as Senior CMC regulatory lead on interactions with health authorities
• Assess regulatory risk associated with CMC and manufacturing decisions
• Provide regulatory oversight for post-approval CMC submissions
• Serve as the Regulatory CMC subject matter expert on cross-functional teams
• Manage regulatory CMC aspects of relationships with collaborators and external manufacturing partners

Required qualifications

• Bachelor’s degree in chemistry, pharmacy, engineering, biochemistry or related science
• 15 or More Years Regulatory CMC experience and/or related pharmaceutical industry experience
• Experience in biologics
• Thorough and extensive knowledge of FDA, EU and global regulations
• Significant experience in developing regulatory strategy for complex products
• Experience in the preparation of CMC sections for complex regulatory submissions
• Excellent understanding of IND, CTA, BLA and MAA processes
• Experience in engaging with health authorities on regulatory CMC topics
• Strong computer and database skills
• Attention to detail, accuracy and confidentiality
• Clear and concise oral and written communication skills
• Excellent organizational skills

Nice to have

• Master's Degree or other advanced degree (Ph.D, PharmD)
• Proficiency in Mandarin Chinese (spoken and written)
• Proficient user of standard Office suite (e.g., Word, Excel)
• experience using electronic document management systems, and document review tools

Benefits

• bonus
• stock
• benefits

Before you apply

• Summit does not accept referrals from employment businesses and/or employment agencies without prior written authorization

About the company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.