RA Principal Specialist Variations Support
RA Principal Specialist Variations Support
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Job Description
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. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.
Baxters 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 liveswhere your purpose accelerates our mission.
Summary
This role is responsible for providing regulatory support for onmarket 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 subteams.
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 subfunctions to provide seamless regulatory support to the project subteam(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
- Bachelors 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 crossfunctional 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 multilocation 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.
Recruitment Fraud Notice
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Required Experience:
Staff IC
Employment Type
Full-Time
