06 Sep
|
Baxter International
|
Gurugram
06 Sep
Baxter International
Gurugram
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.
As a Senior RA Specialist, Regulatory Affairs, you will be responsible for the
execution and maintenance of Regulatory Affairs activities for Baxter's
pharmaceutical and medical device product portfolios across India, while
supporting regulatory activities for Bangladesh and Sri Lanka under limited supervision.
In this role, you will
Supports product registrations, lifecycle management, renewals, variations, regulatory submissions, health authority interactions, and compliance activities to ensure timely product approvals and continued market access.
Works closely with Regulatory Affairs, Quality, Commercial, Supply Chain, Marketing, Global Regulatory Affairs, and distributor partners to support business objectives and regulatory compliance.
Prepare and execute regulatory submissions, renewals, variations, and lifecycle management activities for assigned pharmaceutical and medical device product portfolios in India, while supporting regulatory activities for Bangladesh and Sri Lanka.
Compile, review, and submit regulatory dossiers, authority responses, and supporting documentation in accordance with local regulatory requirements and established timelines.
Support regulatory submissions, authority queries, a
📌 RA Senior Specialist (Gurugram)
🏢 Baxter International
📍 Gurugram