RA Associate

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou will find purpose and pride.

Job Summary

As 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 youll 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 youll bring

• Bachelors degree in B. 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).

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.

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