Job Title: Sr Manager Regulatory CMC

Department: Quality

Location: Menlo Park, US

Job Title: Sr. Manager, Regulatory CMC

Location: Menlo Park, CA

Our Mission:

To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.

Summit Activities

We have in-licensed Ivonescimab, which 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. We are conducting phase-III clinical studies in the following NSCLC indications:

• Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”)
• Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)

Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies

Overview of Role:

The Senior Manager, Regulatory Affairs CMC, 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 on going clinical activities as well as marketing applications.

Role and Responsibilities:

• Represent Regulatory CMC in project teams and provide strategic regulatory CMC input to ensure successful product development
• Develop regulatory CMC strategies and 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

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
• 5 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, MA,A 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 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 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
• Prioritize conflicting demands.
• Work in a fast-paced, demanding and collaborative environment.

The pay range for this role is $177,000 to $192,000 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. 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. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits 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 human resources department to obtain prior written authorization before referring any candidates to Summit.