- 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 business impacts to internal stakeholders.
- Liaise with health authorities, distributors, license holders, and external regulatory partners to support product registrations, regulatory approvals, regulatory queries, and compliance activities.
- Review and support approval of product labeling, artwork, promotional materials, and regulatory documentation to ensure compliance with applicable local regulations and Baxter requirements.
- Support health authority inspections, regulatory audits, recalls, and responses to regulatory queries, observations, and commitments in collaboration with cross-functional stakeholders.
- Collaborate closely with Global Regulatory Affairs, Quality, Supply Chain, Commercial, Marketing, Medical Affairs, and external partners

📌 Sr Spec (Gurugram)
🏢 BAXTER
📍 Gurugram