Sr Specialist, Regulatory Affairs

Baxter

5 - 9 years

9 - 14 Lacs

bengaluru

Posted:3 hours ago| Platform:

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Skills Required

business intelligence reporting publishing excel iso meddra pharma healthcare regulatory affairs recruitment quality management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Collaborate with stakeholders to develop and update processes and standards that will drive greater effectiveness and efficiencies globally
Ensure stakeholders are informed and understand upcoming system and process changes that impact their business including value added.
Collaborate with training manager to ensure training needs of end users are met.
Oversee and participate in testing, validation of systems and processes as needed
Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
May enter data into system or run data reports as needed
SME in areas such as RIM-Veeva Vault, CCDS, XEVMPD/IDMP and Regulatory information quality management
Maintains an expert, current knowledge of regulations, legislation, best practices and guidelines relating to RIM (i.e. GxP, Annex 11, 21 CFR Part 11, ISO standards, etc.).
Ensures that all documents are filed and archived properly in accordance with Baxter requirements.
Hands on experience on Nees, eCTD, or paper regulatory submissions using publishing systems is a plus.
Experience in Verifying documentation to meet submission-ready standards is a plus.

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