Sr Spec - Quality & Regulatory Affairs

Job description

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 efficient 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 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. • Other duties as assigned. ' Education and/or Experience: • 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. • 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 Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud NoticeBaxter 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 Recruitment Fraud Notice.