Sr Specialist, Regulatory Affairs Baxter Medical Devices

5.0 - 7.0 years

0 Lacs

bengaluru, karnataka, india

On-site

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. Job Role: Sr. Specialist, Global Regulatory Affairs Publishing Job Location: Whitefield, Bangalore Essential Duties and Responsibilities Responsible for publishing, reviewing, archiving, and dispatching eCTD, NeeS or paper regulatory submissions for Devices & Drugs Submissions. Responsible for managing regulatory Product Life Cycle activities for electronic Submissions. High Proficiency in managing end-to-end RIMS-Veeva Vault for eCTD/NeeS regulatory submissions. Should have expertise in health authority gateways for submission dispatch i.e. ESG, MHRA portal, CESP, EMA portal. Perform quality control (QC) checks to ensure high quality submission with zero deficiency. Assist with the update of the publishing processes and SOPs. Engage with Global and Regional regulatory teams located across the globe to ensure regulatory activities are aligned to business needs. Supporting stakeholders in managing product registrations and ensuring high quality submissions to Regulatory Authorities. Will have to work independently with minimal support. Proactive tracking of submission status and progress of regulatory filings. Maintenance of Regulatory systems, trackers and databases. Qualifications Bachelor's Degree or equivalent with 5 or more years experience in regulatory electronic document management and/or electronic submission publishing. 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 (ISI Toolbox, eCTDXpress, ISI Publisher, Adobe Acrobat, ISI Writer, Excel, Microsoft word, Databases). Demonstrated leadership, coaching or mentoring skills. Excellent verbal and written English communication skills, suitable for multi-location working relationships. Demonstrated teamwork and collaboration skills. 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 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 .

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