Regulatory Affairs Specialist Require at Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.

Post : Regulatory Affairs Specialist

Job Description
• Create and Review regulatory documentation for Drug, Device and Combination product renewals.
• Interact with non-regulatory support groups (i.e., manufacturing, product stability, quality, clinical, etc.) to request documentation necessary to support product renewals
• Track status and progress of regulatory documentation that will be used for renewals
• Coordinate and compile responses to regulatory authority renewal questions (under supervision)
• Use an electronic document management system to compile documents to support product renewals for submission to Health Authorities
• Answer internal queries for assigned products
• Maintain Database of Regulatory Requirements for renewals
• Knowledge of regulations

• Scientific knowledge
• Administrative and project management skills
• Ability to contribute to multiple projects from a regulatory affairs perspective
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
• Proofreading and editing skills
• Ability to independently identify compliance risks and resolve or escalate as necessary

Additional Information
Location : Bengaluru, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th June 2024