Associate Director, CMC Writing

Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

POSITION SUMMARY

Structure Therapeutics is seeking a highly skilled and experienced Associate Director, CMC Writing to lead the development and authoring of high-quality Chemistry, Manufacturing, and Controls (CMC) documents to support global regulatory submissions and clinical drug development. The Associate Director will collaborate cross-functionally with Regulatory Affairs, Medical Writing, CMC Development, Quality, Nonclinical, and other technical teams to drive strategic and operational excellence in CMC documentation. This will be an individual contributor role reporting to the Director Medical Writing.  This role is based in SSF.  For local candidates, this is a hybrid role that will require 3 days in the office (2 core days, 1 flex day).  We are moving to 4 days/in the office.  If remote, you will be required to work in the SSF office one week/month. #LI-Hybrid

ESSENTIAL DUTIES AND RESPONSIBILITIES

• CMC Regulatory Document Authoring: Lead the writing, editing, and review of high-quality CMC sections of regulatory submissions (drug substance and drug product Quality Modules for submissions to U.S. and non-U.S. Health Authorities in compliance with regulatory requirements, ICH guidelines, and industry standards) as well as briefing packages, reports, protocols, specifications, analytical methods, batch records, investigator brochures, pharmacy manuals
• Cross-Functional Collaboration: Work with various CMC teams and individuals to ensure that all documents are prepared in compliance with regulatory guidelines, company standards, and timelines and supports product development, process validation, tech transfer, and registration activities
• Regulatory Compliance: Ensure all CMC documents comply with ICH guidelines, regulatory requirements, and company quality standards
• Strategic Input: Provide guidance on content organization, messaging, and presentation of CMC data to enhance regulatory acceptance
• Project Leadership: Manage timelines and priorities for multiple projects, ensuring timely delivery of critical CMC regulatory documents

REQUIREMENTS

Education

• Advanced degree (M.S., Ph.D., Pharm.D., or equivalent) in a relevant scientific discipline (e.g., Chemistry, Pharmacy, Chemical Engineering)

Experience

• Minimum of 8 years of experience in CMC regulatory writing within the pharmaceutical or biotechnology industry
• Strong understanding of CMC development, manufacturing processes, analytical testing, and quality control for small molecules
• In-depth knowledge of global regulatory requirements (FDA, EMA, ICH, and other regional agencies) and experience with CMC sections of INDs/CTAs, NDAs/BLAs, and other submissions
• Exceptional technical writing skills, with the ability to translate complex scientific data into clear and concise regulatory documents

Travel – up to 20%

The target salary range for this full-time role is $192,000 - $220,000 bonus equity benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.