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Medical Writing and Regulatory Expert
hace 1 semana
Job Details
The Regulatory Affairs Specialist will be responsible for ensuring the compliance and accuracy of regulatory information across various regions.
This role involves working closely with the RA Lead, RA Labeling Lead, and GLLs (Global Labelling Leads) to ensure the success of various projects and initiatives.
The specialist will also be responsible for managing the Takeda Global Labeling (GL) mailbox, operating in line with QMS documents and non-QMS documents for regulatory services provided, and entering own labeling-related tasks in the IQVIA internal Project Management tool.
Responsibilities
- Manage the Labeling folders on the Share Point and Electronic Content Management (ECM).
- Review all open deliverables on a weekly basis and update as applicable.
- Update the deliverable information and move status to 'Complete' when the deliverable is complete.
Requirements
To be successful in this role, you should have a Bachelor's Degree in Health Sciences or a related field, along with 1-3 years of experience in US labeling activities or 2-4 years of experience in local labeling activities.
You should also possess advanced English skills, including writing and speaking, and be proactive, attentive to details, and willing to learn and be autonomous.
