Job Opportunities API

Wir bei Baxter glauben, dass jeder Mensch – unabhängig von Herkunft oder Identität – ein Recht auf ein gesundes Leben hat. Dieser Grundsatz prägt unser Handeln seit unserer Gründung im Jahr 1931 – und er leitet uns auch heute. Unsere Mitarbeitenden sind durch eine gemeinsame Mission verbunden: Leben zu retten und zu erhalten. Dabei fördern wir eine Kultur, die von Vertrauen, Eigenverantwortung und Teamgeist getragen wird. Jeder bei uns ist ermutigt, Verantwortung zu übernehmen, mitzugestalten und die eigene Wirkung zu entfalten. Wir arbeiten gemeinsam an schlanken, wirkungsvollen Prozessen und übernehmen Verantwortung für exzellente Ergebnisse. Hier finden Sie mehr als einen Job - Sie finden Sinn und Erfüllung. ·        Develop and execute regulatory strategies for product registrations, renewals, variations, lifecycle management activities, and maintenance of existing product licenses across India, while providing regulatory oversight and support for Bangladesh and Sri Lanka. ·        Lead and oversee regulatory submissions, authority queries, approvals, and post-approval activities with health authorities, including management of medical device, pharmaceutical, import, and registration applications through applicable regulatory systems and portals such as SUGAM, ensuring timely approvals and compliance with local regulatory requirements. ·        Establish and maintain effective relationships with health authorities, distributors, license holders, and external regulatory stakeholders to facilitate successful regulatory outcomes.. ·        Lead regulatory support for health authority inspections and regulatory audits, coordinate responses to regulatory observations and commitments, and ensure timely implementation of corrective actions in collaboration with cross-functional stakeholder. ·        Monitor and assess evolving regulatory requirements, regulatory intelligence, and industry trends across India, Bangladesh, and Sri Lanka; evaluate business impact and drive implementation of appropriate regulatory strategies to ensure continued compliance and business growth. ·        Ensure effective product lifecycle management for registered products by performing regulatory assessments and change control evaluations, determining regulatory impact and reporting requirements, implementing labeling and regulatory changes, and ensuring timely submission of post-approval changes, renewals, variations, and regulatory commitments to health authorities. ·        Provide regulatory oversight, guidance, and support to distributors and local representatives to ensure timely execution of registrations, renewals, variations, regulatory notifications, and compliance obligations. ·        Support commercialization initiatives, product launches, portfolio expansion, importation, and supply continuity activities by providing regulatory assessments and recommendations. ·        Review and approve labeling, artwork, promotional materials, and regulatory documentation to ensure compliance with applicable local regulations and Baxter requirements. ·        Represent Regulatory Affairs on cross-functional project teams and collaborate with Global Regulatory Affairs, Quality, Commercial, Supply Chain, Marketing, and other stakeholders to achieve regulatory and business objectives. ·        Lead, develop, and provide guidance to Regulatory Affairs team members, fostering technical competency, regulatory excellence, employee development, and effective execution of business and regulatory objectives. Other assigned tasks Qualifications: Strong knowledge of India and South Asia regulatory requirements and registration processes, including experience with CDSCO regulations, regulatory submissions, approvals, lifecycle management activities, and regulatory systems such as SUGAM. • Strong leadership, project management, communication, stakeholder management, and negotiation skills, with the ability to lead teams, manage complex regulatory projects, identify compliance risks, and effectively collaborate within a matrix and multicultural environment. Education and/or Experience: • Bachelor’s degree in pharmacy, Life Sciences, Biomedical Sciences, Biotechnology, Chemistry, Regulatory Affairs, or a related scientific discipline. • Minimum 7 years of Regulatory Affairs experience within the pharmaceutical, medical device, biologics, nutrition, or healthcare industry. • Experience in product registrations, lifecycle management, and health authority interactions. • Experience managing regulatory activities across India and working with distributors, license holders, or regulatory partners across South Asia in a multinational environment is preferred. Experience using Regulatory Information Management Systems (RIMS), TrackWise, 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 Accommodations Baxter 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 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 Recruitment Fraud Notice .