Specialist- Regulatory Affairs

6 months ago

Bengaluru, India Baxter Full time

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

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

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