Regulatory Affairs Specialist

4 days ago


San Mateo, California, United States RICEFW Technologies Full time

Job Title: CMC Regulatory Affairs Data Entry Specialist

Foster City, CA

Job Summary:

RICEFW Technologies is seeking a highly skilled CMC Regulatory Affairs Data Entry Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for performing data entry using Gilead RIM System to support key CMC RA stakeholders.

Responsibilities:

  • Perform data entry using Gilead RIM System to enter relevant information to support key CMC RA stakeholders.
  • Work collaboratively to support the team by executing routine data entry, such as the input of submission related dates, regulatory assessment comments.
  • Ensure completeness, correctness and consistency of data.
  • Responsible for acquisition of required system skills and knowledge; training supported by manager and peers.
  • Work is performed under the general supervision of more senior Regulatory Affairs CMC professionals.

Requirements:

  • At least 3 years of experience in data entry and management.
  • Familiarity with data entry into complex information systems.
  • Experience with Veeva Vaults, experience with the RIM Vault preferred.
  • Strong verbal and written communication skills and interpersonal skills.
  • Excellent organizational skills and ability to work on multiple concurrent projects with tight timelines are required.
  • Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas is required.
  • Scientific background preferred.
  • Biologics experience is a plus

Why Join Us:

This role is a great opportunity for someone who is passionate about advancing therapeutics against life-threatening diseases, while working with a collaborative team in Regulatory Affairs.

What We Offer:

We are seeking candidates for this position who have a strong interest in data management and entry. Please note that a significant portion of this role involves entering and managing data in complex systems. If you are not enthusiastic about data entry tasks, this position may not be the right fit for you. We encourage applicants who are detail-oriented and eager to contribute to our data processes.



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