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Position Title:  Sr Specialist, Regulatory Affairs

Location: Bangalore

Job Purpose

This role will ensure that data stored and maintained in the Global Regulatory Affairs (GRA) systems is current, accurate, and reliable. The function secures the integrity of data that is used internally for business intelligence / reporting purposes, and externally to comply with global Regulatory agency information requests and obligations. This function may also execute complex submission, compilation and publishing activities associated with electronic submissions

Key Responsibilities

• 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.

Key skills and competencies

• Must have the ability to understand and reduce to practice Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines.
• Scientific knowledge a plus, must have ability to discuss technical matters with cross-functional team members
• Ability to understand changing eCTD regulations and impact to the Baxter processes and systems a plus.
• Ability to operate in a matrixed environment and manage multiple activities, priorities and deadlines
• Exercise independent judgement
• Ability to lead and work with others to drive results
• Experience of working with external pharmaceutical data standards (pharmacopeia, standard terms, ISO, MedDRA, EDQM etc.).
• Experience of working in Microsoft Excel and SharePoint (BI tools is a plus)

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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