RA Principal Specialist, Variations Support

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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 global regulatory impact assessments for changes
Author and manage global submission deliverables for product variation submissions
Responsible for working with other parts of the regulatory organization to achieve desired results
Develop and execute global plans and regulatory submission deliverables for sustaining variations
Support special projects as needed
Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results
Interpret and apply emerging regulatory requirements to ongoing work
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
Track status, quality/compliance and progress of regulatory documentation
Review, edit and proofread regulatory documentation

Qualifications

Bachelor’s Degree or country equivalent in related scientific discipline
Higher degree/PhD will be an advantage
Specialist - 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
Demonstrated leadership, coaching or mentoring skills
Excellent verbal and written English communication skills, suitable for multi-location working relationships
Demonstrated teamwork and collaboration skills
Aptitude for Attention to Detail

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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RA Principal Specialist, Variations Support

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