What are the responsibilities and job description for the Director, Regulatory Affairs position at Crinetics Pharmaceuticals, Inc.?
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Director, Regulatory Affairs
Apply remote type Remote locations Home Office Remote time type Full time posted on Posted 3 Days Ago job requisition id JR000176
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 Director, Regulatory Affairs has direct responsibility for the development and execution of regulatory strategy for development programs. Works closely with the Global Regulatory Program Lead (GRL), Regulatory Affairs team members and project teams to prepare the program regulatory strategy plans, regulatory submissions (authoring, timeline planning, etc.), to support and conduct regulatory activities necessary to ensure the successful preparation and filing of regulatory submissions at Crinetics Pharmaceutical. Establishes and maintains department regulatory processes. The individual will be responsible for developing collaborative and productive partnerships internally, as well as externally with contract research / manufacturing organizations, consultants, and other vendors as required.
Essential Job Functions and Responsibilities :
- Direct accountability for strategic regulatory guidance for the program development teams and oversee budget and accruals within the regulatory group.
- Focus on immediate and short-term (
