16 Aug
|
BAXTER
|
Gurugram
Req # 206413 Location Gurgaon, Haryana, India Job Category Regulatory Affairs Date posted 07/23/2026
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 productive 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.
- 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, approvals, and post-approval activities with Indian health authorities, including medical device, pharmaceutical, import, and registration applications through applicable regulatory systems and portals such as SUGAM.
- Perform regulatory assessments of product, manufacturing, labeling, artwork, supplier, and site changes to determine regulatory impact, reporting requirements, and submission strategies.
- Maintain product registrations and regulatory approvals by ensuring timely completion of renewals, post-approval changes, commitments, regulatory notifications, and lifecycle management activities.
- Monitor changes in regulatory requ
📌 Sr Spec (Gurugram)
🏢 BAXTER
📍 Gurugram