Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. 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 a robust preclinical and clinical development pipeline. 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. Join our team as we transform the lives of others.
Position Summary
The Senior Regulatory Project Manager will play a crucial role in driving, supporting, and managing regulatory submissions and project management activities in close partnership with the Global Regulatory Lead, Filing Lead, and Product PM. This individual will collaborate closely with cross-functional teams to drive the planning, preparation, and execution of regulatory submissions, ensuring timely and compliant delivery. This position offers an excellent opportunity to contribute to the development of life-changing therapies and make a significant impact on patients' lives.
Essential Job Functions And Responsibilities
These may include but are not limited to:
- Develop and manage detailed regulatory project timelines, ensuring alignment with overall project goals and company objectives.
- Coordinate and support the logistical execution of regulatory submissions (e.g., INDs, CTAs, NDAs, MAAs) according to established timelines and regulatory requirements.
- Partner with the Product PM for appropriate integration into the Global Product Team strategy, timelines, and reporting.
- Organize and facilitate Filing/Submission sub-team meetings, planning, and prep meetings, as well as IR/RFI meetings with agendas, attendee management, minutes, decisions, and action-items.
- Facilitate cross-functional communication and collaboration between Regulatory Affairs and other departments (e.g., Clinical, Nonclinical, CMC).
- Work closely with document authors to organize document review meetings and establish timelines for high-quality regulatory documents, including developing presentations and reports.
- Proactively identify and manage potential risks and challenges to ensure project success.
- Track and manage regulatory milestones and deadlines, ensuring adherence to regulatory requirements.
- Contribute to the development and improvement of regulatory processes and tools.
- Maintain knowledge of current regulatory guidelines and requirements.
- Assist in creating PM tools, templates, and best practices, contributing to PMO initiatives.
- Manage PPAM or enterprise projects from initiation, planning, execution to control, and closing phases; oversee and mitigate project risks and issues and report on project status.
Required
Education and Experience:
- Bachelor’s degree in a scientific discipline (e.g., biology, chemistry, pharmacology).
- 8+ years of experience in the biopharma industry with 3+ years in a regulatory affairs or project management role within the pharmaceutical or biotechnology industry.
- Proven track record of successfully leading and managing regulatory submissions.
- In-depth knowledge of drug development processes and global regulatory guidelines (e.g., FDA, EMA).
- Strong PM fundamentals (meeting facilitation & management, timeline management, critical path assessment, risk and issues management).
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and project management software (e.g., Smartsheet, Planisware, MS Project).
- Excellent communication, organizational, leadership, and interpersonal skills.
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 communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
Travel
You may be required to travel for up to 5% of your time.
The Anticipated Base Salary Range: $121,000-$151,000
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.
Equal Opportunity Employer
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Vaccination Requirement
Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
