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Senior Regulatory Operations Specialist

  • Job type: Permanent
  • Location: San Diego, California
  • Salary: Competitive
  • Job reference: 344321/004_1565730548
  • Sector: EPM Scientific, Regulatory
  • Date posted: 13/08/2019

Title: Senior Regulatory Operations Specialist

Company Summary

One of the most exciting biopharma companies in California is rapidly growing and developing its teams to carry out the progress of its robust pipeline. With a specialized approach, this firm is able to treat unmet disease across multiple therapeutic areas. They've proved themselves more than successful with 3 different treatments already on the market and over 10 indications in the clinic. A company of this girth will not only allow for the mentorship from truly talented professionals, but also career development where you will contribute to all functions of Regulatory.

Overview

We are looking for a detail oriented and personable Regulatory Operations Specialist who has experience handling and compiling large documents. This individual should also be skilled in formatting and familiar with new and updated processes. Lastly, as the Regulatory operations Specialist, you will be responsible to jump on board with a knowledge of relevant formatting software such as Toolbox, eCTDManager, Acrobat, and Veeva Vault.

Responsibilities

  • Review, compile, and format all Regulatory documents/amendments/submissions

  • Format documents into the eCTD format

  • Review R&D documents to ensure compliance with standards

  • Publish Regulatory submissions, ensuring timely submissions of high quality, compliant, and valid submissions

  • Responsible for the accuracy of information

  • Work well with a team

  • Work cross-functionally

  • Work hands-on in a dynamic fast-paced environment

Experience and Qualifications

  • Minimum of 2-4+ years directly related to professional pharmaceutical experience with document management technology and electronic publishing

  • Experience with ISI Toolbox, eCTDManager, Veeva Vault, Acrobat, etc.

  • Extensive experience with Microsoft software such as MS Word and MS Excel

  • Excellent written and oral communication skills

  • Ability to work independently and take direction from a mentor

  • Interpret Regulatory Affairs documents, submissions, and reports

  • Excellent verbal and written communication skills

Education

  • Minimum of bachelor's degree or above is required

If you are interested in the Senior Regulatory Operations Specialist role, do not hesitate to apply!

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