Senior Manager, Regulatory Operations

Cullinan Oncology

Cullinan Oncology

Legal, Operations
United States
Posted on Thursday, June 6, 2024
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.
We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.
Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.
We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.
With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.
The Sr. Manager, Regulatory Operations primary responsibility isRIM Data Management Standards and Training. A key responsibility of this role is to identify and recommend improvements to business processes, regulatory data, and data definitions for the RIM platform, while working in close collaboration with other Global Regulatory Operations (GRO), Global Regulatory Affairs (GRA) and cross-functional stakeholders (e.g., IT, Clinical, Nonclinical, Quality). This role will identify opportunities within the RIM platform to enhance compliance, efficiency, and reporting. The individual will be responsible for supporting all RIM Reporting and Analytics needs across Global Regulatory Affairs. In addition, this role will be responsible for ensuring effective system support and training programs are developed and delivered to system end users.

Position Responsibilities:

  • Lead/support the efforts to align regulatory and key business stakeholder processes to a RIM enterprise data strategy.
  • Lead/support implementation, maintenance, and governance of E2E RIM platform.
  • Ensure user’s requirements are adequately documented and serve as the basis for system continuous improvement, reengineering, and/or new system selection.
  • Partner with cross-functional business functions in RFI/RFP efforts for system implementation or update due to evolving business needs, new electronic standards, or health agency requirements.
  • Lead/support the implementation and maintenance of a scalable RIM data governance model.
  • Ensure data reporting capability in a complete, accurate, and timely manner through data quality monitoring methods for systems (e.g., Health authority interactions and country/regional product release).
  • Participate in and monitor industry forums and user groups (e.g., Veeva Connect), and agency information sources, to help identify and influence best practices and emerging electronic standards, ensuring that stakeholder and system impact analysis are embedded into an overall action and/or project plan.
  • Support the management of submission records and associated global product registration records.
  • Develop and maintain the GRO tools and corresponding training and initiatives.
  • Contribute to and or lead applicable meetings related to system upgrades and maintenance changes.
  • Organize and drive regulatory system change controls and related documentation and training materials.
  • Create and make readily available regulatory system training and demos to users.

Candidate Requirements:

  • BA/BS degree or equivalent combination of education, experience, and training.
  • 5+ years industry experience in a biotechnology or pharmaceutical Regulatory Affairs Operations environment with demonstrated ability to present and articulate requirements.
  • Working knowledge of regulations, processes and industry standards that govern regulated systems, records retention, and computer validation requirements for the management of regulatory-focused content, throughout product lifecycle stages, including 21 CFR Part 11 and Annex 11 compliance.
  • Strong working knowledge of submission requirements and guidelines for all submission types, both paper and electronic and strong experience in the regulatory submission process.
  • Demonstrated ability to facilitate, lead and manage the establishment of procedures.
  • Excellent written, verbal, and interpersonal communication skills to effectively communicate cross-functionally.
  • Experience managing technology projects (e.g., eDMS, eCTD publishing tools, etc.)
  • Proficiency with MS-Office Suite and Adobe Acrobat, including pdf plug-ins that support submission readiness. Knowledge of MS Word Templates, their function and use. Working knowledge of Adobe Acrobat PDF Bookmarks and Hyperlinks.
  • Experience with document management and Regulatory Information Management (RIM).
  • Familiarity with formatting of regulatory submission documents to ensure compliance with external and internal submission-ready standards.
Cullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.