Regulatory Information Management Associate
hace 5 días
Position Details
This Regulatory Affairs Specialist position requires experience in US labeling activities or local (own country or LATAM) labeling activities. The ideal candidate will be able to accurately distribute CCDS to relevant stakeholders and update the Regulatory Information System to capture submission due dates, deferred submission dates, and CCDS events on hold due to pending basis label approvals.
Main Tasks
- Ensures RIM systems are up-to-date with regard to Labeling CCDS events, including creation of Global Project Plans (GPP).
- Distributes CCDS accurately to relevant stakeholders.
- Updates the Regulatory Information System to capture submission due dates, deferred submission dates, and CCDS events on hold due to pending basis label approvals.
- Supports the GLL with CCDS template/content transfers and Submission Ready Quality Check (SRQC).
- Assists the Labeling Lead and Global Labeling Leads with administrative tasks.
- Manages the Takeda Global Labeling (GL) mailbox in line with GL mailbox Job Aid.
- Manages labeling folders on Share Point and Electronic Content Management (ECM).
- Operates within QMS documents and non-QMS documents for regulatory services provided.
- Enters labeling-related tasks in the IQVIA internal Project Management tool.
- Reviews open deliverables on a weekly basis and updates as applicable.
Requirements
- Bachelor's Degree in Health Sciences or related field.
- Experience in US labeling activities: requirements, submissions, legislation, compliance. OR experience in local (own country or LATAM) labeling activities.
- Advanced English: writing and speaking.
- Proactive, attentive to details, good command of communication, willing to learn things and be autonomous.
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