Director, Regulatory Affairs

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:

These may include but are not limited to:

• 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 (<2 Years) strategic planning horizon.
• Oversee/develop department policies and procedures to achieve department and corporate goals.
• Ensure adequate resources are in place to successfully complete regulatory projects and programs.
• In collaboration with program GRL, responsible for development of global regulatory strategies/regulatory program plans to support nonclinical and clinical activities across various development programs.
• Independently develop, maintain, and communicate timelines for IND submissions, CTAs, amendments, briefing documents and other regulatory documents as needed.
• In collaboration with the program GRL, independently lead execution of major regulatory submission activities, (eg, IND, CTA, Pre-IND Mtg, EOP 2 Mtg, Pre-NDA Mtg, NDA submission preparation) including development of timelines and submission strategies, leadership of cross functional submission teams, with direct responsibility for quality of submission content/execution.
• Provide regulatory leadership and strategic regulatory expertise on cross-functional product development teams to resolve complex project issues.
• Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to facilitate attainment of regulatory health authority approval.
• Maintain an awareness, through regulatory intelligence, of global regulatory strategies for products in the same class/indication and determine applicability to Company programs.
• Effectively interact with all contributors/cross-functional stakeholders and Regulatory Affairs management to ensure timely delivery of documents for regulatory submission.
• Independently lead, coordinate, author, critically review and provide strategic input on regulatory filing documents.
• Provide guidance to project teams to ensure complete, accurate, high quality and electronically functional regulatory submissions.
• In collaboration with the program GRL and/or senior regulatory leadership, independently prepare and present regulatory status updates, summaries of regulatory issues, and program regulatory plans to product governance committees including the program development teams, leadership teams and executive management.
• Provide critical strategic regulatory review of clinical study documentation, including review of clinical protocols, informed consent documents, clinical study recruitment materials and clinical study reports.
• Lead regulatory research and analysis, develop, and communicate recommendations regarding new/emerging regulations to management and project teams.
• Independently develop and maintain standard operating proc