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Regulatory Manager

Company Name: Tanvex BioPharma USA, Inc.
Location: Irvine, CA
Job Type: Exempt, Full-Time
Contact Name: Richelle Rivera
Phone: 949-307-5748
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.


Job Description

Supports clinical & regulatory department with cross-functional projects, submission requirements, and specific regulatory and development initiatives as required.

The following reflects essential functions for this job but does not restrict the tasks that may be assigned.

  • Serves as the RA representative on project teams, as assigned.
  • Leads preparation and cross-functional review of content for cover letters, relevant background and any questions for regulatory bodies to accompany new protocols, protocol amendments, meeting briefing packages, clinical information requests and amendments, and other clinical related submissions (e.g. statistical analysis plans, special protocol assessment requests) to the company’s regulatory applications (e.g. INDs, NDAs, as applicable) and assures integrity of all related submissions
  • Leads preparation of content for responses to FDA clinical requests for information.
  • Assists with annual Investigator Brochure reviews/updates and submissions to the IND under the direction of the Vice President, Clinical & Regulatory
  • Prepares clinical sections for new or amended product labeling to ensure accuracy of data from referenced studies and accuracy of conclusions as supported by individual or integrated reports
  • Assists the PM in assessing compliance for the conduct of clinical studies via adherence to GCP and FDA regulations
  • Develops and maintains working knowledge of regulations/guidance/regulatory landscape for focus area
  • Leads in preparation of submissions (or applicable sections thereof) with clinical focus area content prior to transmittal to regulatory bodies
  • Maintains Regulatory Affairs documentation, as required.
  • Supports assembling of content for periodic reporting requirements to include marketing application annual reports and investigational new drug annual reports under the direction of regulatory lead personnel.
  • Researches and compiles data for regulatory department as requested
  • Effectively communicates regulatory requirements within project teams so that scope, timelines and budgets can be assembled accordingly.
  • Independently develop project timelines and budgets as required.


Job Requirements

  • Minimum Bachelors Degree in Life or Engineering Science, advanced science or medical related degrees desirable
  • Experience with BLA submissions and PAI inspections
  • Good writing and strong organizational skills required.
  • Demonstrated communication and human relation skills.