Regulatory Affairs Assistant

i-Pharm Consulting; Cambridge; On-site; GBP 25,000 - 35,000

Job description

Job Title: Regulatory Affairs Assistant

Contract Duration: 12 Months

Location: United Kingdom, Cambridge

Key Responsibilities:

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

Requirements:

1. Should have familiarity with data entry into complex information systems.
2. Should have experience with Veeva Vaults; experience with the RIM Vault preferred.
3. Strong verbal and written communication skills and interpersonal skills.
4. Excellent organizational skills and ability to work on multiple concurrent projects with tight timelines are required.
5. Basic understanding of the role of Regulatory Affairs and regulatory requirements in a limited number of areas is required.
6. Scientific background preferred.
7. Biologics experience is a plus.