RA Sr. Specialist, Variations Support
3 weeks ago
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Summary
This role is responsible for providing regulatory support for on-market products. Activities include change assessment, variation planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project sub-teams.
Essential Duties and 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 documentationQualifications
Bachelor’s Degree or country equivalent in related scientific discipline Higher degree/PhD will be an advantage Sr. Associate - Minimum of 5 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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