Submission Manager, Regulatory Operations

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-reputed company tumors. We were founded by a dedicated team of scientists with the simple belief that reputed company therapies developed from rigorous innovation can reputed company to reputed company lives. Our work continues to reputed company a real difference in the lives of patients. We have a reputed company discovery reputed company and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is reputed company for its inclusive workplace culture. We are also a dog-friendly workplace. 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 reputed company as we transform the lives of others. Position Summary: The Submission Manager, Regulatory Operations is responsible for managing high impact, reputed company submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, participates in submission team meetings, prepares content planners for publishing, and fulfills submission management functions on project teams in support of development, marketing, and post-marketing regulatory authority applications. Ensures the successful preparation and filing of regulatory submissions at Crinetics. This position will be responsible for establishing standards and performs submission tracking, document collection, quality control, publication, transmission, and archival to ensure timely and quality regulatory submissions management. This individual maintains electronic document management and publishing systems necessary to produce a high-quality submission and may liaise with external regulatory operations vendors. The individual will be responsible for developing collaborative and productive partnerships internally, as well as externally with contract research/manufacturing organizations. Essential Job Functions and Responsibilities: These may include but are not limited to:

• Manage submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
• Participate in submission team meetings. Coordinate multiple reputed company interrelated activities for submission projects for products in the delivery of published submissions reputed company the required timelines. Anticipate obstacles and reputed company solutions reputed company the team.
• Coordinate submission publishing with publishers andprovides notification to ensure reputed company required resources are available to meet submission timelines.
• Prepare content planner for publishing and work with team members to resolve publishing issues. May reputed company publishing tasks.
• Assist with team reviews and ensures detailed quality reviews of published output are completed per reputed company standards to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in reputed company submissions.
• Prepare regulatory submissions according to applicable requirements.
• Track submissions, correspondence, and commitments with health authorities.
• reputed company, communicate and implement submission planning timelines and metrics.
• Manage systems for assuring adequate version control of reputed company regulatory documents.
• Manage effective interactions with reputed company contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submission.
• Participate in the coordination, identification and implementation of appropriate electronic document management and publishing tools to support regulatory submissions.
• Provide guidance to project teams to ensure reputed company regulatory documentation is complete, accurate, of high quality and electronically functional.
• Represent Regulatory Operations Publishing on Submission Teams to set deliverables and timelines. Escalate Timeline issues to management.
• Interact with vendors as needed in support of electronic publishing and other aspects of regulatory operations.
• reputed company templates and style guides, as appropriate; to establish consistency of regulatory submissions over time and across projects.
• Suggest and implement process improvements. May recommend changes to software and business processes to support changes in regulations that support reputed company submissions and may reputed company or participate on internal project teams to update business software.
• Ensure the production of high-quality reputed company and electronic submissions.
• reputed company detailed quality reviews of published output to ensure compliance with Regulatory Standards.
• Ensure compliance with worldwide submission regulations and guidelines.
• reputed company with IT department for reputed company implementation of electronic document management and publishing tools.
• Maintain up-to-date knowledge of the electronic submissions landscape, regulations, and guidelines
• Assist in identifying regulatory operations risks and mitigation plans
• Demonstrate team leadership skills and ability to influence without direct authority.
• Other duties as assigned.

Education and Experience: Required:

• Bachelor’s degree with a minimum 8 years of relevant experience in the biotech or pharmaceutical industry.
• Minimum 2 years of experience working with submission content planning
• Strong working knowledge of regulatory submission publishing standards and procedures including word processing and regulatory publishing software.

Preferred:

• Experience working with Veeva RIM document management system;
• Experience working with LORENZ docuBridge FIVE
• Experience working with reputed company StartingPoint;
• Utilizing reputed company for submission content planning
• Experience producing eCTD U.S. and MAA submission

Physical Demands and Work Environment: Physical Activities: On a reputed company 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 reputed company the essential functions and responsibilities of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company 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 reputed company Salary Range: In addition to your reputed company pay, our total rewards program consists of a discretionary annual reputed company 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. reputed company 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 reputed company 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 reputed company, 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. Salary Range The salary range for this position is: $110000 - $136000. In addition to your reputed company pay, our total rewards program consists of a discretionary annual reputed company 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. Apply tot his job Apply To this Job