Manager, Regulatory Submission

Crinetics Pharmaceuticals • Headquarters, KY

3d • $110,000 - $136,000

About The Position

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. Crinetics is known 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 our team as we transform the lives of others. Position Summary: The Submission Manager, Regulatory Operations is responsible for managing high impact, complex 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.

Requirements

• 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.

Nice To Haves

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

Responsibilities

• 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 concurrent interrelated activities for submission projects for products in the delivery of published submissions within the required timelines.
• Anticipate obstacles and develop solutions within the team.
• Coordinate submission publishing with publishers andprovides notification to ensure all required resources are available to meet submission timelines.
• Prepare content planner for publishing and work with team members to resolve publishing issues.
• May perform publishing tasks.
• Assist with team reviews and ensures detailed quality reviews of published output are completed per current standards to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in complex submissions.
• Prepare regulatory submissions according to applicable requirements.
• Track submissions, correspondence, and commitments with health authorities.
• Develop, communicate and implement submission planning timelines and metrics.
• Manage systems for assuring adequate version control of all regulatory documents.
• Manage effective interactions with all 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 all 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.
• Develop 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 complex submissions and may lead or participate on internal project teams to update business software.
• Ensure the production of high-quality paper and electronic submissions.
• Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards.
• Ensure compliance with worldwide submission regulations and guidelines.
• Interface with IT department for all 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager