RA Sr. Associate, Variations Support
Baxter
Bangalore, Karnataka,India
5d 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.

    Role Summary

    Position Title : RA Sr. Associate, Variations Support

    Job Purpose

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

    Key Responsibilities

    Review and provideregulatory impact assessments for changes

    Support globalsubmission deliverables for product variation submissions

    Responsible for workingwith other parts of the regulatory organization to achieve desired results.

    Execute global plansand regulatory submission deliverables for sustaining variations

    Utilize regulatoryknowledge to prepare submission deliverables that will achieve desired results

    Ensure identifiedstandards and content requirements are met for regulatory submissions

    Timely, activelysupport query responses

    Engage with GlobalBusiness Unit Regulatory teams and Regional Regulatory teams to ensureregulatory activities are in alignment with business requirements

    Interface and alignwith other regulatory affairs sub-functions to provide seamless regulatorysupport to the project sub-team(s).

    Maintain regulatoryfiles in a format consistent with requirements

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

    Review, edit andproofread regulatory documentation

    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

    Experience operating ina regulated environment

    Ability to operate in amatrixed environment and manage multiple activities, priorities and deadlines

    Exercise independentjudgement

    Scientific knowledgeand ability to discuss technical matters with cross-functional team members

    Knowledge ofregulations and ability to communicate and apply

    Ability to identifycompliance risks and escalate when necessary

    Excellent verbal andwritten English communication skills, suitable for multi-location workingrelationships

    Demonstrated teamworkand collaboration skills

    Aptitude for Attentionto Detail

    Qualification

    Bachelor’s Degree or countryequivalent in related scientific discipline

    Higher degree / PhD willbe an advantage

    Past Experience

    Sr. Associate - Minimumof 2 years’ regulatory experience in RA or related healthcare environment

    Higher degree / PhD will be an advantage

    Regulatory Affairs

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