Regulatory Affairs Assistant
4 days ago
Job Summary:
Innova Solutions is seeking a highly skilled Regulatory Affairs Assistant - II to join our team. As a key member of our Regulatory Affairs department, you will be responsible for performing data entry using Client RIM System to enter relevant information 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.
Requirements:
- 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.
Preferred Qualifications:
- Biologics experience is a plus.
What We Offer:
Innova Solutions offers a competitive pay range of $55.00-$60.00 per hour, as well as a comprehensive benefits package, including medical and pharmacy coverage, dental and vision insurance, 401(k), health savings account, flexible spending account, life insurance, pet insurance, short-term and long-term disability, accident and critical illness coverage, pre-paid legal and ID theft protection, sick time, and other types of paid leaves.
About Innova Solutions:
Innova Solutions is a global technology and business transformation solutions provider, employing approximately 50,000 professionals worldwide. We deliver strategic solutions to our clients, enabling them to operate as leaders within their fields. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment.
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