Baxter is hiring B. Pharma/ M. Pharma Freshers as a Regulatory Affairs Specialist – Apply Now

Job Responsibility for Regulatory Affairs Specialist at Baxter

• 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 & Skills for Regulatory Affairs Specialist at Baxter

• 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