RA Principal Specialist, Variations Support

Baxter is hiring a RA Principal Specialist, Variations Support in Bengaluru, India. The role involves providing regulatory support for on-market products, including change assessments, submission documentation, and collaboration with regulatory teams. Candidates should have a Bachelor’s degree, at least 5 years of regulatory experience, and strong communication skills. The position emphasizes teamwork, attention to detail, and the ability to manage multiple priorities in a regulated environment.
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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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