Regulatory Affairs Assistant
3 weeks ago
Job Title: Regulatory Affairs Assistant
Contract Duration: 12 Months
Location: United Kingdom, Cambridge
Key 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:
- Should have familiarity with data entry into complex information systems.
- Should have 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.
To apply or find out more, please contact Sharleney Chandraratna at schandraratna@i-pharmconsulting.com or call +44 (0) 2075510732.
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