Director, Regulatory Affairs Strategy

Crinetics is a pharmaceutical company based in San Diego, California, developing 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 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 Director, Regulatory Affairs Strategy will be responsible for defining and implementing regulatory strategy for development programs. Works closely with the Regulatory Affairs team members and project teams to prepare 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:

• Provide strategic regulatory leadership for development teams.
• Collaboratively develop global regulatory strategies to support nonclinical and clinical activities across development programs.
• Develop and submit regulatory dossier (including INDs, CTA, IMPDs, NDAs, DMF’s, briefing packages, MAA’s, or other regulatory dossier) with the help of Crinetics’ staff and consultants.
• Articulate complex regulatory issues to project teams and external stakeholders to support global development and commercialization of drug candidates.
• Manage interactions and communications with FDA and ex-US regulatory authorities.
• Provide regulatory representation and expertise on cross-functional product development teams as needed.Maintain an awareness, through regulatory intelligence, of global regulatory strategies for products in the same class/indication and determine applicability to Company programs.
• Conduct regulatory research and analysis, develop and communicate recommendations regarding new/emerging regulations to management and project teams.
• Develop and maintain standard operating procedures, department working practices, templates and style guides, as appropriate.
• Ensure the company is adhering to all applicable government regulations, submission regulations and guidelines.
  

Education and Experience:
Required:

• Minimum BS in biological sciences or related discipline with at least 12 years of Regulatory Affairs experience in a biopharmaceutical company with a proven record of significant regulatory experience and accomplishments.
• At least 8 years in a management role overseeing individuals in a high performing team environment.
• Thorough knowledge and understanding of US CFR requirements for investigational and commercial products. Familiar with EU requirements for clinical trials applications and marketing authorizations.
• RAC certification or equivalent is preferred.
• Prior experience working at a small company with wide ranging related responsibilities is desired.
• Prior experience managing third parties and external service providers (worldwide) and consultants is preferred.
• Excellent writing skills as they relate to preparation of regulatory documents.
• Excellent interpersonal skills with strong oral/written communication and presentation skills.
• Excellent negotiation skills and a tactful approach that leads to high value on outcomes achieved.
• Excellent problem-solving ability.
• Excellent command of GXPs (eg, GMPs, GLPs and GCPs).
• Leadership and management skills, and, demonstrated qualities in this area.
• Demonstration of cross-functional understanding related to drug development.
• Good judge of risks and a keen ability to analyze options and manage outcomes.
• Well versed with the latest trends in the drug development industry.
  

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: $161,000 - $215,000
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.