Associate Director, Regulatory CMC

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

Overview

About Summit 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. Summit believes in building a team of world class professionals who are passionate about this mission, and its people drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and commitment to people. Our employees are the heart and soul of our culture, invaluable in shaping our journey toward excellence.

Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:

Regulatory Studies

• Non-small Cell Lung Cancer (NSCLC)

• HARMONi: Phase 3 evaluating ivonescimab with chemotherapy versus placebo plus chemotherapy in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC previously treated with a 3rd generation EGFR TKI.
• HARMONi-3: Phase 3 evaluating ivonescimab with chemotherapy versus pembrolizumab with chemotherapy in first-line metastatic NSCLC.
• HARMONi-7: Phase 3 evaluating ivonescimab monotherapy versus pembrolizumab monotherapy in first-line metastatic NSCLC.

• Colorectal Cancer (CRC)

• HARMONi-GI3: Phase 3 evaluating ivonescimab in combination with chemotherapy versus bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by regulatory authorities other than China’s NMPA. Summit is headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland.

Hybrid: 4 days On-Site at one of our physical locations: Palo Alto, CA; Princeton, NJ; Miami, FL.

Overview Of Role

The Associate Director, Regulatory Affairs, CMC is responsible for coordinating and preparing high-quality global regulatory filings. This role provides regulatory strategy input and oversees preparation of regulatory submissions in collaboration with CMC, Supply Chain and QA. The Associate Director provides regulatory guidance on Chemistry, Manufacturing and Controls (CMC) regulatory activities for assigned product(s) in coordination with key internal stakeholders. This role manages regulatory CMC aspects of compounds (large molecules) through all phases of development and provides strategic and operational management of preparation and maintenance of CMC regulatory filings to support ongoing clinical activities as well as marketing applications.

Role And Responsibilities

• Planning, development and finalization of high-quality Regulatory CMC documents to meet global regulatory requirements.
• Represent Regulatory CMC in project teams and provide strategic regulatory CMC input to ensure successful product development.
• Work closely with CMC, Supply Chain, Quality and Regulatory Affairs to develop global regulatory strategies and prepare submissions for approval for assigned products.
• Manage internal review and approval process for CMC related submissions.
• Coordinate the planning and preparation of Health Authority meeting requests, briefing books and responses to Health Authority information requests.
• Manage timelines for assigned projects in alignment with company goals.
• Review CMC sections of regulatory submissions (IND, IMPD, BLA, etc.) for compliance with regulatory requirements and alignment with company strategies.
• RA support in interactions with Health Authorities (HA), as needed.
• Identify areas of continuous process improvement and engage RA teams and key stakeholders as necessary.
• Provide interpretation of global CMC regulations and guidelines to Summit personnel for assigned programs.
• Provide regulatory impact assessment to CMC changes and deviations and plan, prepare and manage related regulatory submissions as necessary.
• Escalate issues that affect regulatory compliance to CMC RA Management.
• Maintain up-to-date knowledge of global regulations and guidances pertaining to CMC issues.

Experience, Education And Specialized Knowledge And Skills

• Bachelor's Degree in Chemistry, Pharmacy, Engineering, Biochemistry or related science required; Master’s or advanced degree preferred.
• 6+ years Regulatory CMC experience and/or related pharmaceutical industry experience required.
• Experience in biologics required.
• Thorough and extensive knowledge of FDA and EU regulations required.
• Experience in preparation of CMC sections for regulatory submissions (IND, IMPD, BLA, MAA, Amendments, Supplements, etc.).
• Understanding of IND, CTA, BLA and MAA.
• Proficiency in Mandarin Chinese (spoken and written) is highly desirable.
• Proficient user of standard Office applications; experience with electronic document management systems and document review tools desirable.
• Strong computer and database skills; attention to detail, accuracy, and concise communication skills.
• Excellent organizational skills; critical thinking and problem solving; ability to multi-task and manage time-sensitive, highly confidential work.
• Ability to communicate and articulate complex ideas clearly; prioritize conflicting demands; work in a fast-paced, collaborative environment.

Compensation and Benefits

This is the pay for this position.

Pay Transparency

$194,000 - $199,000 USD

Actual compensation packages are based on several factors unique to each candidate, including skill set, depth of experience, certifications, and location. This may differ in other locations due to differences in the cost of labor. The total compensation package may also include bonus, stock, benefits and/or other variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies for vacancies posted on this site. All employment businesses/agencies must contact Summit’s Talent Acquisition team at [e-mail] for authorization before referring candidates.

Summit Therapeutics Inc. is an Equal Opportunity Employer and maintains a diverse environment. We do not discriminate in recruitment, hiring, training or promotion based on race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.