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Regulatory Affairs Specialist
1 month ago
Innova Solutions is seeking a highly skilled Regulatory Affairs Assistant - II to join our team. As a key member of our Regulatory Affairs team, you will be responsible for performing data entry using our Client RIM System to support key CMC RA stakeholders.
Key Responsibilities:- Perform data entry using Client 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.
- Familiarity with data entry into complex information systems.
- Experience with Veeva Vaults, experience with the RIM Vault preferred.
- Excellent organizational skills and ability to work on multiple concurrent projects with tight timelines.
- Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas.
- Scientific background preferred.
- Biologics experience is a plus.
- Basic understanding of Regulatory Affairs.
- Scientific background preferred.
- Biologics experience is a plus.
Innova Solutions is a global technology and business transformation solutions provider. We deliver strategic solutions to our clients, enabling them to operate as leaders within their fields. We are committed to providing a work environment free of discrimination and harassment.
