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Manager/Sr. Manager, Regulatory Publishing/Operations at Crinetics Pharmaceuticals
San Diego, CA, US
San Diego, CA
 
The Manager/Sr. Manager, Regulatory Publishing/Operations will be responsible for the conduct of regulatory operations necessary to ensure the successful preparation and filing of regulatory submissions at Crinetics Pharmaceutical.  Establishes standards and performs submission tracking, document collection, quality control, publication, transmission, and archival to assure timely and quality regulatory submissions management. Maintains electronic document management and publishing systems necessary to produce a high-quality submission and acts as the primary liaison 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.
 
Responsibilities

These may include but are not limited to:

  • Preparation of regulatory submissions according to applicable requirements
  • Tracking submissions, correspondence, and commitments with health authorities
  • Develop, communicate and implement submission planning timelines and metrics
  • Develop and maintain systems for assuring adequate version control of all regulatory documents
  • Maintain effective interactions with all contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submission
  • Facilitate and coordinate the 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
  • Select and manage vendors 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
  • Ensure the production of high-quality paper and electronic submissions
  • Ensure compliance with worldwide submission regulations and guidelines
  • Interface with IT Dept. for all implementation of electronic document management and publishing tools
  • Maintain up-to-date knowledge of the electronic submissions landscape, regulations, and guidelines
  • Responsibility for identifying regulatory operations risks and mitigation plans
  • Other duties as assigned
Qualifications
  • Bachelor’s degree in scientific area preferred.  Equivalent combination of relevant education and applicable job experience may be considered
  • Minimum of 5 years of relevant Regulatory Publication/Operations experience in a biotech/pharmaceutical setting
  • Understanding of all International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and FDA guidance relevant to electronic regulatory submissions
  • Experience and knowledge in the preparation of global regulatory submissions with primary focus on electronic publishing of US IND and/or NDA sequences (additional experience with Clinical Trial Authorizations (CTA) and Marketing Authorization Application (MAA) helpful)
  • Ability to work both independently with direction and within project teams and see all projects through to their completion
  • Excellent verbal and written communication skills
  • Strong organizational skills, including the ability to prioritize workload
  • Strong interpersonal skills and the ability to deal effectively with other people/departments
  • Ability to meet deadlines and perform multiple tasks in a fast-paced setting
About Crinetics
 
Crinetics Pharmaceuticals Inc.is a rare endocrine and endocrine-related tumor therapeutics company.  Crinetics’ benefit package includes health insurance, stock options, a 401k, ESPP, and paid time off. Crinetics is a dog-friendly workplace.