Job Description

This is where you save and sustain livesAt 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.Driven by Our Purpose, Destined to TransformEverything we do converges at the critical intersection where products that save and sustain lives meet the healthcare professionals and caregivers who make it all happen. Now, we support more patients through every point of their journey, with a broad set of solutions that empowers healthcare professionals to deliver smarter, more personalized care. Together, we are transforming healthcare with bold innovations that will help us realize our shared promise to improve care for all.While everyone at Baxter has a shared passion for our mission, the R&D teams play a critical role in our ability to save and sustain lives. Scientists and engineers in R&D work together to develop, test, and launch products that enhance patient care.We encourage teamwork and collaboration and prioritize building relationships with each other. It's easy to do because we all share common traits of reliability, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable.Job Role: Associate, Global Regulatory AffairsJob Location: Whitefield, BangaloreJob SummaryAs a Global Regulatory Affairs - Associate, you are responsible for providing regulatory support for change assessments, submission preparation for product registrations and submitting regulatory dossiers using various publishing tools for drugs, biologics & medical devices. Supporting various phases of product life cycle, generate capability towards fundamental global regulatory requirements and different regulatory pathways. Collaborating with cross-functional teams within the organization, including R&D, quality assurance and manufacturing departments. Ability to take ownership of tasks and deliver without supervision while using their expertise to seek help when necessary.What you\'ll be doing

• Engage with Global and Regional regulatory teams located across the globe to ensure regulatory activities are aligned to business needs for various drugs, biologics & medical devices submissions.
• Supporting stakeholders in managing product registrations and ensuring high quality submissions to Regulatory Authorities.
• Responsible for Regulatory Product Life Cycle Management Activities.
• High Proficiency in Trackwise8 to handle Change Control Process and RIMS-Veeva Vault for Regulatory Submissions.
• Tracking of status and progress of regulatory filings
• Maintenance of Regulatory systems, trackers and databases.

What you\'ll bring

• Bachelors degree in B. Tech (Bio Tech) from a reputed institution with 0-2 years of relevant experience.
• Sound understanding of ISO 13485, ISO 14971, IEC 62304 standards.
• Must possess strong analytical thinking, and excellent organizational and communication skills.
• Candidate must be able to work in a team-oriented, fast-paced environment.
• Strong technical skills (Excel, Microsoft word, Databases).

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 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 .

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