Job Description
Job title: Asst Mgr, Regulatory Affairs
Company: Baxter
Job description: 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. This role is responsible for providing regulatory support for on-market products in India, Sri Lanka, Nepal & Bangladesh: Mapping structure flow for Regulatory lifecycle of product from registration to commercialization. Preparation, Review and Submission of Dossiers for Medical Devices, Biologicals and Pharmaceutical Products (Fresh filings, Re-Registration, Query Responses) as per the Guidelines and as per the Timelines given to obtain marketing authorization in India and Neighboring countries (Sri Lanka, Nepal and Bangladesh) Responsible for change control assessment from regulatory perspective and timely reporting of post approval changes to respective regulatory authorities Review of SOP related to Pharmacovigilance, Company Core Data Sheet (CCDS), Labeling, etc. from regulatory perspective. Reviewed labeling and package inserts for accuracy and completeness. Review, Prepare and regulatory submission of various CCDS. Co-ordination of all Labeling activities with Global teams for in-time implementation of labels and package inserts as per applicable regulations. Regulatory support to tender teams for successfully accomplishing tender document requirements. Work in close co-ordination with cross functional team to ensure and maintain business continuity. Responsible for the scrutiny of Technical documents for shipment clearance. Responsible for the document database management and archival of the critical documents Assist in the preparation of technical presentations meetings with regulator. Ensures tracking and compliance with evolving regulations and interpretations Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .
Expected salary:
Location: Gurgaon, Haryana
Job date: Mon, 03 Oct 2026 03:4+:35 GMT
Apply for the job now
Company: Baxter
Job description: 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. This role is responsible for providing regulatory support for on-market products in India, Sri Lanka, Nepal & Bangladesh: Mapping structure flow for Regulatory lifecycle of product from registration to commercialization. Preparation, Review and Submission of Dossiers for Medical Devices, Biologicals and Pharmaceutical Products (Fresh filings, Re-Registration, Query Responses) as per the Guidelines and as per the Timelines given to obtain marketing authorization in India and Neighboring countries (Sri Lanka, Nepal and Bangladesh) Responsible for change control assessment from regulatory perspective and timely reporting of post approval changes to respective regulatory authorities Review of SOP related to Pharmacovigilance, Company Core Data Sheet (CCDS), Labeling, etc. from regulatory perspective. Reviewed labeling and package inserts for accuracy and completeness. Review, Prepare and regulatory submission of various CCDS. Co-ordination of all Labeling activities with Global teams for in-time implementation of labels and package inserts as per applicable regulations. Regulatory support to tender teams for successfully accomplishing tender document requirements. Work in close co-ordination with cross functional team to ensure and maintain business continuity. Responsible for the scrutiny of Technical documents for shipment clearance. Responsible for the document database management and archival of the critical documents Assist in the preparation of technical presentations meetings with regulator. Ensures tracking and compliance with evolving regulations and interpretations Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .
Expected salary:
Location: Gurgaon, Haryana
Job date: Mon, 03 Oct 2026 03:4+:35 GMT
Apply for the job now
💡 Quick Summary
Seeking a career-building opportunity? The Asst Mgr| Regulatory Affairs | Gurgaon| Haryana | Baxter position is now open for candidates interested in the Operations Executive Jobs sector. This role in Anywhere offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Operations Executive Jobs is a plus.