Regulatory Affairs Coordinator
hace 5 días
Company Overview
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Job Description
The Regulatory Affairs Specialist will provide support for activities conducted by the RA Lead, RA Labeling Lead, and GLLs (Global Labelling Leads).
This role involves ensuring RIM systems are up-to-date with regard to labeling CCDS events, including the creation of Global Project Plans (GPPs).
Responsibilities include distributing CCDS to relevant stakeholders, updating the Regulatory Information System, and supporting the GLL with CCDS template/content transfers and Submission Ready Quality Check (SRQC).
The specialist will also assist the Labeling Lead and Global Labeling Leads with administrative tasks, manage the Takeda Global Labeling (GL) mailbox, and operate in line with QMS documents and non-QMS documents for regulatory services provided.
Required Skills and Qualifications
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.
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