Sr Specialist, Regulatory Affairs Bengaluru

Sr Specialist, Regulatory Affairs Bengaluru

03 Aug
|
BAXTER
|
Bengaluru

03 Aug

BAXTER

Bengaluru

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for effective and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Summary
This role is responsible for providing regulatory support for on-market products. Activities include change assessment, variation planning and submission, creation of submission documentation, identification of local submission requirements, product/facility change management, process support,



and participation in project sub-teams.

Essential Duties and Responsibilities
Review and provide regulatory impact assessments for changes
Support global submission deliverables for product variation submissions in Europe, USA, and RoW countries.
Responsible for working with other parts of the regulatory organization to achieve desired results.
Execute global plans and regulatory submission deliverables for sustaining variations
Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results
Ensure identified standards and content requirements are met for regulatory submissions
Timely, actively support query responses
Engage with Global and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirements
Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the proje

📌 Sr Specialist, Regulatory Affairs Bengaluru
🏢 BAXTER
📍 Bengaluru

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