Associate Director, CMC Strategy and Submissions

About CG Oncology, Inc.

Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.

Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

About the role

The Associate Director, CMC strategy and Submissions will serve as an integral member of the Tech Ops team. The role will provide guidance and support for regulatory submissions and related documents within Tech Ops cross-functional team. This individual will help provide guidance to functional areas heads on the overall CMC strategy discussions as it pertains to M3 and other regulatory documents.

Location: Remote

Essential Functions

• Ability to review and understand manufacturing or analytical changes, identify M3 sections that may need to be revised based on the planned changes.
• Initiate submission planning activities such as kick off mtg plans and slides based on the planned changes
• Build a strong understanding of CMC issues and their overall impact on submission strategies
• Work with CMC team to align CMC assumptions and submission strategy and provide guidance on requirements as per the guidance documents
• Coordinate authoring and review activities within Tech Ops for M3 sections for IND-As and BLA as needed.
• Support authoring of non-complex CMC sections such as analytical methods, batch analysis based on the source documents.
• Facilitate cross-functional team discussions within Tech Ops to resolve comments and move CMC submissions to next steps
• Maintain submission specific trackers for CTD sections and supportive source documents, work with SMEs and functional owners to ensure all documents are uploaded to support submission activities
• Maintain understanding of CMC submission activities and their impact on supply chain needs
• Sound understanding of CTD sections of Module 3 and working knowledge of applicable guidance docs as their pertain to CG products
• Work and communicate effectively with internal or external stakeholders.
• Independently lead assigned tasks, manage timelines and escalate issues as needed
• CMC strategy representative on assigned projects in cross-functional working teams
• Ability to review guidance documents and provide input/guidance on relevant topics

Qualifications

• BSc or MSc in chemistry, Biology, or a related discipline.
• 10+ years of experience in a pharmaceutical or a biotechnology company
• Sound understanding of industry practices in manufacturing, testing and supply chain
• Sound knowledge of cGMP regulations and compliance requirements
• Good understanding of release specifications, stability and related issues
• Experience in reviewing CMC sections for Regulatory submissions
• Strong written and verbal communication skills
• Strong organizational skills and ability to effectively manage multiple priorities and projects
• Knowledgeable of (ICH) and GMP regulations.

Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.