Regulatory Affairs Specialist

5 days ago

San Mateo, California, United States Unicon Pharma Inc Full time
Job Overview

Unicon Pharma Inc is seeking a highly skilled Regulatory Affairs Assistant to join our team. As a key member of our Regulatory Affairs department, you will play a crucial role in ensuring the accuracy and completeness of data entry in our RIM System.

Key Responsibilities:

  • Perform data entry tasks using our RIM System to support key CMC RA stakeholders.
  • Collaborate with the team to execute routine data entry, such as inputting submission related dates and regulatory assessment comments.
  • Ensure data accuracy, completeness, and consistency.
  • Develop and maintain system skills and knowledge, with training supported by manager and peers.
  • Work under the general supervision of senior Regulatory Affairs CMC professionals.

Requirements:

  • Familiarity with data entry into complex information systems.
  • Experience with Veeva Vaults, with 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.
  • Basic understanding of Regulatory Affairs and regulatory requirements in a limited number of areas.
  • Scientific background preferred.
  • Biologics experience is a plus.

Preferred Qualifications:

  • At least 2-3 years of experience in a related field.
  • Familiarity with data management and entry.
  • Strong attention to detail and ability to work independently.

What We Offer:

Unicon Pharma Inc is a dynamic and collaborative team dedicated to advancing therapeutics against life-threatening diseases. We offer a unique opportunity for someone who is passionate about data management and entry to join our team and contribute to our data processes.

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