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Summary
This role is responsible for providing regulatory support for on-market products. Activities include change assessment, variation planning and submission, 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
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Review and provide regulatory impact assessments for changes
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Support global submission deliverables for product variation submissions in Europe, USA, and RoW countries.
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Responsible for working with other parts of the regulatory organization to achieve desired results.
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Execute global plans and regulatory submission deliverables for sustaining variations
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Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results
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Ensure identified standards and content requirements are met for regulatory submissions
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Timely, actively support query responses
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Engage with Global and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirements
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Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s).
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Maintain regulatory files in a format consistent with requirements
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Tracking of status, quality/compliance and progress of regulatory documentation
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Review, edit and proofread regulatory documentation
Qualifications
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Bachelor’s Degree or country equivalent in related scientific discipline
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Higher degree/PhD will be an advantage
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Sr. Specialist - Minimum of 8 - 10 years of regulatory experience in RA or related healthcare environment
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Experience operating in a regulated environment
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Ability to operate in a matrixed environment and manage multiple activities, priorities and deadlines
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Exercise independent judgement
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Scientific knowledge and ability to discuss technical matters with cross-functional team members
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Knowledge of regulations and ability to communicate and apply
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Ability to identify compliance risks and escalate when necessary
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Excellent verbal and written English communication skills, suitable for multi-location working relationships
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Demonstrated teamwork and collaboration skills
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Aptitude for Attention to Detail
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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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