Sr Specialist, Regulatory Affairs

This is where you save and sustain lives

At 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.

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 link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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