Associate Director, Regulatory CMC

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