Associate Director, Regulatory CMC — Global Submissions & Strategy

Summit Therapeutics, Inc.; Palo Alto (CA); Hybrid; USD 194,000 - 199,000; Full time

Job summary

Summit Therapeutics, Inc. is seeking an experienced Associate Director of Regulatory Affairs, CMC to coordinate global regulatory filings. This role requires a Bachelor's degree in Chemistry or related field, at least 6 years of Regulatory CMC experience, and thorough knowledge of FDA and EU regulations. The position focuses on managing CMC regulatory aspects and preparing submissions. The salary range for this position is approximately $194,000 - $199,000 USD per year, based on experience and skills. Hybrid work-model applies, with office presence in California.

Qualifications

• 6+ years of experience in Regulatory CMC and/or pharmaceutical industry.
• Experience in biologics required.
• Knowledge of FDA and EU regulations.

Responsibilities

• Prepare high-quality global regulatory filings.
• Oversee regulatory submissions in collaboration with stakeholders.
• Manage CMC aspects of compounds throughout development phases.
• Provide regulatory guidance and ensure compliance.

Skills

Regulatory CMC experience

Knowledge of FDA and EU regulations

Proficiency in Mandarin Chinese

Attention to detail

Critical thinking

Organizational skills

Education

Bachelor's Degree in Chemistry or related field

Master’s or advanced degree preferred

Tools

Standard Office applications

Electronic document management systems

Job description

Summit Therapeutics, Inc. is seeking an experienced Associate Director of Regulatory Affairs, CMC to coordinate global regulatory filings. This role requires a Bachelor's degree in Chemistry or related field, at least 6 years of Regulatory CMC experience, and thorough knowledge of FDA and EU regulations. The position focuses on managing CMC regulatory aspects and preparing submissions. The salary range for this position is approximately $194,000 - $199,000 USD per year, based on experience and skills. Hybrid work-model applies, with office presence in California.