RA Associate, Global Renewals Support
Baxter
Bangalore, Karnataka,India
7d ago

AboutBaxter

  • Baxter provides a broad portfolio of essentialrenal and hospital products, including home, acute and in-centre dialysis;
  • sterile IV solutions; infusion systems and devices; parenteral nutrition;surgery products and anesthetics; and pharmacy automation, software andservices.

    The company’s global footprint and the critical nature of itsproducts and services play a key role in expanding access to healthcare inemerging and developed countries.

    Baxter’s employees worldwide are buildingupon the company’s rich heritage of medical breakthroughs to advance the nextgeneration of healthcare innovations that enable patient care.

    Position Title : RA Associate,Global Renewals Support

    Job Purpose :

    As part of the Global RegulatoryAffairs organization, this position will interact with regional colleagues(i.e. Middle East and Africa, Latin America, Europe, Asia Pacific, USA etc.

    toprepare regulatory submissions needed to maintain approved Drug and Deviceapplications and ensure alignment with current regulations, regulatoryguidelines, and manufacturing operations.

    Key responsibilities :

  • Interact with non-regulatory support groups (i.e. manufacturing, product stability, quality, clinical, etc.) to request documentation necessary to support product renewals
  • Track status and progress of regulatory documentation that will be used for product renewals
  • Review regulatory documentation
  • Coordinate and compile responses to regulatory authority renewal questions (under supervision)
  • Use an electronic document management system to compile documents to support product renewals for submission to Health Authorities (under supervision)
  • Answer internal queries for assigned products
  • Maintain Database of Regulatory Requirements for renewals
  • A CareerThat Matters

    Baxter’s employees are united in a mission tosave and sustain lives. We are passionate about applying scientific innovationto meet the needs of the millions of people worldwide who depend on ourmedically necessary therapies and technologies.

    We focus on increasing accessto healthcare, innovating in crucial areas of unmet need, and pursuing creativecollaborations that bring our mission to life for patients every day.

    EqualEmploymentOpportunity

    Baxter is an equal opportunity employer. Baxter evaluates qualified applicantswithout regard to race, color, religion, gender, national origin, age, sexualorientation, gender identity or expression, disability / handicap status or anyother legally protected characteristic

    Qualifications

    Key skills and competencies :

  • Scientific background (i.e., chemistry, microbiology, biochemistry, pharmacy, engineering, etc.) desired
  • Demonstrated interpersonal skills, detail oriented, and solid organization skills
  • Able to manage multiple projects and adapt as priorities change
  • Strong written and oral communication skills (English language)
  • Identify alternate options to issues and negotiate with country RA
  • Ability to identify issues and effectively communicate when necessary
  • Ability to lead and coach others
  • Qualification :

    Bachelor’s degree or country equivalent, preferably in a scientific discipline

    Regulatory Affairs

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