Manager, Regulatory CMC

Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and robust pipeline across preclinical and clinical development. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Come join our team as we transform the lives of others.

Position Summary:

The Manager, Regulatory CMC will report to the Senior Director, Regulatory CMC and will be responsible for executing CMC regulatory strategy for Crinetics’ products and ensuring that Regulatory CMC submissions are aligned with Health Authority requirements and Crinetics’ product development objectives. The position will provide support for both development stage and future marketed products and work closely with cross functional development and commercial teams to implement development plans.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Provide operational regulatory CMC input and support for multiple innovative programs.
• Serve as a regulatory representative on study execution and submission teams and work closely with CMC departments to create and execute on global regulatory submissions.
• Participate in planning and preparation for health authority responses and negotiations.
• Responsible for compilation and submission of high-quality CMC related sections of INDs/CTAs/NDAs/MAAs, including responses to questions from various regulatory authorities, working in collaboration with subject matter experts in the CMC and Quality departments.
• Create and maintain CMC regulatory timelines and CMC regulatory systems
• Work with regulatory and CMC management, ensure reporting requirements, including annual and periodic reports, are in compliance with applicable regulations and guidelines.
• Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.
• Assist in the development and maintenance of Regulatory SOPs.
• Support interactions with regulatory agencies during inspections.
• Other duties as assigned

Education and Experience:

Required:

• Bachelor’s degree required in a relevant life sciences degree, and at least 8 years strategic regulatory experience and a minimum of 5 years regulatory CMC experience in the biotech/pharmaceutical industry.  (An equivalent combination of experience and education may be considered.)
• Master’s or PhD strongly preferred.
• Experience preparing CMC sections from early- through late-stage development and pre- and post-approval submissions (e.g., INDs/BLAs/NDAs/MAAs/Annual Reports/IMPDs) and familiarity with eCTD structure and granularity requirements.
• Knowledge of US, EMA, and ICH regulations/guidance pertaining to the development, manufacture, and distribution of investigational and commercial drug products and the associated regulatory submission elements.
• Understanding of GMP requirements
• Experience with electronic document control and management systems
• Ability to work and prioritize several projects at once while balancing multiple and overlapping timelines
• Ability to write clearly at a level appropriate to the audience and the project with careful attention to detail and accuracy with a focus on CMC regulatory writing skills
• Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally
• Desire to work in a collaborative team setting

Preferred:

• Experience with Orphan Drug Designation, breakthrough therapy, and direct interactions supporting health authority GMP inspections
• Considerable experience with development of CMC development, process validation, comparability protocols, amendments, and supplements
• Knowledge of both foreign (ex-US) regulations pertaining to the development, manufacturing and distribution of investigational and commercial drugs

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communi