Summit Therapeutics, Inc.
Manager, Regulatory CMC
Summit Therapeutics, Inc., Menlo Park, California, United States, 94029
Overview
The Manager, Regulatory Affairs CMC, is responsible for coordination and preparation of Chemistry, Manufacturing and Controls (CMC) regulatory submissions 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 on-going clinical activities as well as marketing applications. Role and Responsibilities
Regulatory representative on specific multi-discipline teams, may be responsible for organizing and leading meetings and acts independently to identify and resolve problems Manage CMC regulatory filings in US and ex-US clinical and marketing applications 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 appropriate 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 guidance pertaining to CMC issues All other duties as assigned 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 A minimum of 3+ 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 processes Proficiency in Mandarin Chinese (spoken and written) is highly desirable Proficient user of Office suite (Word, Excel), experience using electronic document management systems, and document review tools desirable Strong computer and database skills Attention to detail, accuracy and confidentiality Clear and concise oral and written communication skills Excellent organizational skills Critical thinking, problem solving, ability to work independently Must be able to effectively multi-task and manage time-sensitive and highly confidential documents Communicate effectively and articulate complex ideas in an easily understandable way Work in a fast-paced, demanding and collaborative environment Compensation and Benefits
The pay range for this role is $135,000-$150,000 annually. 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. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. This range is provided by Summit Therapeutics, Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Company and Role Context
Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi, HARMONi-3, and HARMONi-7. Ivonescimab is an investigational therapy not approved in Summit’s license territories, with marketing authorization granted in China in May 2024 and Fast Track designation by the FDA for the HARMONi clinical trial setting. Summit does not accept referrals from employment businesses and/or employment agencies for vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
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The Manager, Regulatory Affairs CMC, is responsible for coordination and preparation of Chemistry, Manufacturing and Controls (CMC) regulatory submissions 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 on-going clinical activities as well as marketing applications. Role and Responsibilities
Regulatory representative on specific multi-discipline teams, may be responsible for organizing and leading meetings and acts independently to identify and resolve problems Manage CMC regulatory filings in US and ex-US clinical and marketing applications 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 appropriate 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 guidance pertaining to CMC issues All other duties as assigned 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 A minimum of 3+ 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 processes Proficiency in Mandarin Chinese (spoken and written) is highly desirable Proficient user of Office suite (Word, Excel), experience using electronic document management systems, and document review tools desirable Strong computer and database skills Attention to detail, accuracy and confidentiality Clear and concise oral and written communication skills Excellent organizational skills Critical thinking, problem solving, ability to work independently Must be able to effectively multi-task and manage time-sensitive and highly confidential documents Communicate effectively and articulate complex ideas in an easily understandable way Work in a fast-paced, demanding and collaborative environment Compensation and Benefits
The pay range for this role is $135,000-$150,000 annually. 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. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. This range is provided by Summit Therapeutics, Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Company and Role Context
Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi, HARMONi-3, and HARMONi-7. Ivonescimab is an investigational therapy not approved in Summit’s license territories, with marketing authorization granted in China in May 2024 and Fast Track designation by the FDA for the HARMONi clinical trial setting. Summit does not accept referrals from employment businesses and/or employment agencies for vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
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