Baxter Jobs

Baxter
Baxter

Job Information

Baxter RA Sr. Associate, Variations Support in Bangalore, United States

Are you looking for a career that matters?

We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

https://www.youtube.com/watch?v=X0h_0ih8MgQ

Summary

This role is responsible for providing regulatory support for on-market products. Activities include change assessment, variation planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project sub-teams.

Essential Duties and Responsibilities

  • Review and provide regulatory impact assessments for changes

  • Support global submission deliverables for product variation submissions

  • Responsible for working with other parts of the regulatory organization to achieve desired results.

  • Execute global plans and regulatory submission deliverables for sustaining variations

  • Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results

  • Ensure identified standards and content requirements are met for regulatory submissions

  • Timely, actively support query responses

  • Engage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirements

  • Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s).

  • Maintain regulatory files in a format consistent with requirements

  • Tracking of status, quality/compliance and progress of regulatory documentation

  • Review, edit and proofread regulatory documentation

Qualifications

  • Bachelor’s Degree or country equivalent in related scientific discipline

  • Higher degree/PhD will be an advantage

  • Sr. Associate - Minimum of 2 years’ regulatory experience in RA or related healthcare environment

  • Experience operating in a regulated environment

  • Ability to operate in a matrixed environment and manage multiple activities, priorities and deadlines

  • Exercise independent judgement

  • Scientific knowledge and ability to discuss technical matters with cross-functional team members

  • Knowledge of regulations and ability to communicate and apply

  • Ability to identify compliance risks and escalate when necessary

  • Excellent verbal and written English communication skills, suitable for multi-location working relationships

  • Demonstrated teamwork and collaboration skills

  • Aptitude for Attention to Detail

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

Our products and therapies touch the lives of millions of people around the world every day, which is why we are focused on transformative innovations that bring smarter, more personalized care to all of us. For 87 years and counting, we have been at the critical intersection where the ideas that save and sustain lives meet the providers who make it all happen. And now, we are determined to realize our boldest opportunities to transform global healthcare for years to come.

DirectEmployers