• Perform data entry, 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.

• Should have familiarity with data entry into complex information systems.
• Should have experience with Vaults, experience with the RIM Vault.
• 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

Required Years of Experience: At least 2 – 3 years of experience

• Top 3 Required Skill Sets: Familiarity with data entry into complex information systems; strong verbal and written communication skills; experience with Vault, including RIM
• Top 3 Nice to Have Skill Sets: Basic understanding of Regulatory Affairs; scientific background preferred; biologics experience is a plus
• Unique Selling Point of this role: 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.
• Required Degree or Certification B.S. preferred