Spec, RA

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.

• Ensure the on-time filing of high-quality regulatory submissions and to assist in the preparation maintenance and control of regulatory Dossiers.
• Interact with all levels in the organization and across several functions particularly Compliance Marketing R&D engineering manufacturing and QA/QC.
• Participate in discussions to provide strategic regulatory guidance to team members in India and other Region operations.
• Interact with regulatory agency on regulatory submissions and follow ups of drug products.
• Oversee the preparation and filing of high-quality submissions to regulatory authorities.
• Ensure that all applications are filed in accordance with regulations and requirements.
• Provide regulatory guidance to staff and inter-disciplinary project teams.
• Be a proactive member of the Regulatory team to ensure Baxters continuing compliance with regulatory authorities.
• Continue to develop quality standards and procedures for RA.
• Facilitate product development/Launch activities for respective Markets

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.