Work as Regulatory Affairs Senior Specialist at Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.

Post : RA Senior Specialist (Regulatory Affairs)

Job Description
• 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, 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 to support regulatory submissions, product launches, lifecycle management activities, compliance initiatives, supply continuity, and business objectives.

Candidate Profile
• Bachelor's Degree in Pharmacy, Life Sciences, Biomedical Sciences, Biotechnology, Chemistry, Regulatory Affairs, or a related scientific discipline.
• Minimum 5 years of Regulatory Affairs experience within the pharmaceutical, medical device, biologics, nutrition, or healthcare industry, including product registrations, lifecycle management, regulatory assessments, and health authority interactions.
• Strong knowledge of India and South Asia regulatory requirements, including CDSCO regulations, SUGAM submissions, product registrations, lifecycle management, regulatory intelligence, compliance activities, and health authority interactions.
• Strong project management, communication, stakeholder management, coordination, and negotiation skills, with the ability to manage multiple regulatory activities, identify compliance risks, escalate issues when necessary, and collaborate effectively within a matrix and multicultural environment.
• Experience supporting regulatory activities in India and working with distributors, license holders, or regulatory partners across South Asia is preferred.
• Experience using Regulatory Information Management Systems (RIMS), TrackWise, SUGAM, and other regulatory management tools is preferred

Additional Information
Experience : Minimum 5 years
Qualification : Bachelor's Degree in Pharmacy, Life Sciences, Biomedical Sciences, Biotechnology, Chemistry, Regulatory Affairs
Location : Gurgaon, Haryana
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th September 2026