Regulatory Affairs Specialist
16 hours ago
RICEFW Technologies is seeking a highly skilled and detail-oriented CMC Regulatory Affairs Data Entry Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for performing data entry using Gilead RIM System to support key CMC RA stakeholders.
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.
- Familiarity with data entry into complex information systems.
- 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.
- Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas.
- Scientific background preferred.
- Biologics experience is a plus.
We are seeking candidates who have a strong interest in data management and entry. This role is a great opportunity for someone who is passionate about advancing therapeutics against life-threatening diseases, while working with a collaborative team in Regulatory Affairs.
Please note that a significant portion of this role involves entering and managing data in complex systems. If you are not enthusiastic about data entry tasks, this position may not be the right fit for you.
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Regulatory Affairs Specialist
2 weeks ago
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Regulatory Affairs Expert
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
3 weeks ago
San Mateo, California, United States Presidio Medical, Inc. Full timeJob SummaryThe Principal Regulatory Specialist will play a key role in ensuring the overall regulatory compliance of Presidio Medical, Inc. with applicable regulatory bodies and the Presidio Quality Management System (QMS). This position is responsible for participating in design control projects, evaluating document change orders for regulatory assessment,...
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Regulatory Affairs Specialist
1 week ago
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CMC Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
2 weeks ago
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Regulatory Affairs Specialist
2 weeks ago
San Diego, California, United States Tandem Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices.Key ResponsibilitiesPrepare and maintain domestic and international regulatory filings...
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San Diego, California, United States Bayside Solutions Full timeJob Title: Regulatory Specialist, R&DJob Summary:We are seeking a highly skilled Regulatory Specialist to join our R&D team. As a key member of our team, you will be responsible for implementing worldwide regulatory programs for developing and marketed products, interacting with regulatory authorities to expedite approvals, and providing regulatory expertise...
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