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 Sr. Associate, Variations Support
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.
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.
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
Key skills and competencies
Experience operating ina regulated environment
Ability to operate in amatrixed environment and manage multiple activities, priorities and deadlines
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
Bachelor’s Degree or countryequivalent in related scientific discipline
Higher degree / PhD willbe an advantage
Sr. Associate - Minimumof 2 years’ regulatory experience in RA or related healthcare environment
Higher degree / PhD will be an advantage