Regulatory Specialist

2 weeks ago


Bengaluru, Karnataka, India Baxter Full time

Improve Patient Lives with Baxter

We are on a journey to revolutionize kidney care and other vital organ support. Vantive, a new company built on our legacy, will provide best-in-class care to the people we serve.

Key Responsibilities:

  • Provide regulatory support for on-market products, including change assessment, variation planning, and submission documentation.
  • Review and provide regulatory impact assessments for changes.
  • Support global submission deliverables for product variation submissions.
  • Work with 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 support query responses.

Requirements:

  • Bachelor's Degree or country equivalent in a 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.


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