Associate Director, Regulatory CMC

Associate Director, Regulatory CMC

Palo Alto, CA (US)

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. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are 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:

• Non-small Cell Lung Cancer (NSCLC)
• HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
• HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
• HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
• Colorectal Cancer (CRC)
• HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has 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 will provide regulatory strategy input, and oversee preparation of regulatory submissions in collaboration with other stakeholders including CMC, Supply Chain and QA. The Associate Director is responsible for providing regulatory guidance on Chemistry, Manufacturing and Controls (CMC) regulatory activities for assigned product(s) in coordination with key internal stakeholders. This role will manage regulatory CMC aspects of compounds (large molecules) through all phases of development and provide 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
• Works closely with the CMC, Supply Chain, Quality and Regulatory Affairs team in developing global regulatory strategies and preparing submissions for the 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
• Identify areas of continuous process improvement and engaging RA teams and key stakeholders as necessary.
• Support in providing 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 any related regulatory submissions as necessary.
• Escalate issues that affect regulatory compliance, promptly 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 and Master's Degree or other advanced degree preferred
• 6 or More 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)
• A good understanding of IND, CTA, BLA and MAA
• Proficiency in Mandarin Chinese (spoken and written) is highly desirable
• Proficient user of standard of Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
• Strong computer and database skills
• Attention to detail, accuracy and
• Clear and concise oral and written communication skills
• Excellent organizational skills
• Critical thinking, problem solving, ability to work
• Must be able to effectively multi-task and manage time-sensitive and highly confidential
• Communicate effectively and articulate complex ideas in an easily understandable way
• Prioritize conflicting
• Work in a fast-paced, demanding and collaborative

This is the pay for this position

Pay Transparency

$194,000 - $199,000 USD

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's Talent Acquisition team at View email address on click.appcast.io to obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.