Regulatory Affairs Assistant - II*

Job Title: CMC Regulatory Affairs, Data Entry Contractor Position
Contract Duration: 6 months (we would like to start with 6 months, with the potential to extend if the person is highly competent and a good resource for our team)
Location: Remote- If the candidate is in the Foster City, CA area, we would prefer that they are onsite 2-3 days if possible

• Perform data entry using *** 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.

Knowledge & Skills
• 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

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 Veeva Vault, including RIM
Top 3 Nice to Have Skill Sets: Basic understanding of Regulatory Affairs; scientific background preferred; biologics experience is a plus