16 Aug
|
Baxter International
|
Gurugram
16 Aug
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 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 requirements, regulatory intelligence, and industry trends, and communicate relevant risks, requirements, and potential b
📌 Sr Spec (Gurugram)
🏢 Baxter International
📍 Gurugram