Sr. Director, Regulatory Affairs (CMC Regulatory)

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

Guide the overall CMC regulatory strategy globally and manage the required resources to meet an aggressive regulatory submission schedule, ensuring the effective fulfillment of company goals and objectives.  This will be an individual contributor role reporting to Sr. VP, Regulatory Affairs and Quality. 

• Preference is for local candidates, and we are moving to a 4-day work week/in the SSF QC office
• If remote, you will be required to work in SSF QC office one week a month

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Direct successful preparation and approval of Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), New Drug Application (NDA), Marketing Authorization Application (MAA), and other CMC regulatory submissions
• Develop, compile, maintain, and review 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
• Take a leading role in meetings with Health Authorities. Prepare information packages and query responses
• Participate in and/or lead cross-functional teams
• Independently manage and prioritize multiple complex projects and work responsibilities
• Maintain cooperative and success-driven relationships with Clinical, Quality, and other departments within Structure. Interact productively with CMOs, consultants, and other stakeholders
• Effectively supervise, manage, and direct the activities of employees in your group
• Work with various CMC teams and individuals to ensure that CMC documentation (e.g., protocols, reports, specifications, analytical methods, batch records) meets regulatory requirements and effectively supports product development, process validation, tech transfer, and registration activities · Research and provide analysis of current US and international CMC regulations and guidance
• Actively participate on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements
• Actively participate with Global Regulatory Leads to develop content of container labels
• Review and guide content of CMC information in nonclinical and clinical documents, including clinical protocols, pharmacy manuals, investigator brochures, and prescribing information · Communicate critical issues to senior Management

REQUIREMENTS

Education 

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

Experience

• Minimum of 10 -12 years of experience in global regulatory affairs, with a focus on CMC, in the pharmaceutical or biotechnology industry
• Extensive prior experience in independently authoring IND, IMPD, NDA, MAA CMC sections
• Thorough understanding of phase-appropriate data requirements for regulatory filings
• Demonstrated record of strong leadership and teamwork in cross-functional industry environments
• Excellent written and verbal communication skills
  
• Highly organized, with the ability to multi-task and handle pressure well
• Meticulous attention to detail
• Ability to think through a project or task of diverse complexity and execute independently from beginning to end

Travel – up to 20%

The target salary range for this full-time role is $255,000 - $306,000 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.