Director, Regulatory Affairs CMC

The role

The Director, Regulatory Affairs CMC coordinates and prepares high-quality global regulatory filings. This role provides regulatory strategy input and oversees CMC regulatory activities for large molecule compounds through all development phases.

What you will do

• Develop and execute CMC regulatory strategies for Clinical Phase and Commercial Development
• Manage the preparation of high quality Regulatory CMC submissions including IND, IMPD, BLA, MAA and post approval supplements
• Represent Regulatory CMC in project teams and provide strategic regulatory CMC input
• Work with CMC, Supply Chain, Quality and Regulatory Affairs teams to implement Regulatory Strategies
• Plan and participate in the preparation of Health Authority meeting requests, briefing books and responses
• Review CMC sections of regulatory submissions for compliance and alignment with company strategies
• Lead and participate in Regulatory interactions with Health Authorities
• Develop Regulatory CMC strategies and Risk assessments for assigned projects
• Identify areas of continuous process improvement
• Support providing interpretation of global CMC regulations and guidelines to Summit personnel

Required qualifications

• Bachelor’s degree in chemistry, pharmacy, engineering, biochemistry or related science
• 10 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
• Proficiency in Mandarin Chinese (spoken and written)
• Proficient user of standard of Office suite (e.g., Word, Excel)
• Experience using electronic document management systems
• Experience using document review tools

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.