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Regulatory Affairs Specialist

1 month ago

Bengaluru, Karnataka, India Baxter Full time

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Our team is dedicated to providing regulatory support for on-market products, ensuring compliance with local regulations and standards.

Key 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 6 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