RA Principal Specialist, Variations Support
Req # JR - 167714
Location: Bengaluru, Karnataka, India
Job Category: Regulatory Affairs
Date Posted: 04/22/2025
About Baxter
At Baxter, we are united by our mission to save and sustain lives. With products and therapies used in hospitals, clinics, and homes worldwide, we are dedicated to transforming healthcare. Join us to contribute to life-changing innovations and be a part of a company that makes a real impact on global healthcare.
Summary:
This role is responsible for providing regulatory support for on-market products, specifically for managing change assessments, variation planning, submission documentation creation, and ensuring alignment with global and local submission requirements. The role also includes participating in project sub-teams and providing process support.
Essential Duties and Responsibilities:
Review and provide global regulatory impact assessments for product changes.
Author and manage global submission deliverables for product variation submissions.
Collaborate with other parts of the regulatory organization to ensure desired results.
Develop and execute global plans for sustaining variations and regulatory submission deliverables.
Support special projects as required.
Prepare regulatory submission deliverables that meet desired results using regulatory knowledge.
Stay informed about emerging regulatory requirements and apply them to ongoing work.
Ensure compliance with content and standards for regulatory submissions.
Respond to queries in a timely and active manner.
Engage with global and regional regulatory teams to align regulatory activities with business needs.
Collaborate with other regulatory affairs sub-functions to provide seamless support.
Maintain regulatory files in compliance with required formats.
Track status, quality, and compliance of regulatory documentation.
Review, edit, and proofread regulatory documentation.
Qualifications:
Bachelor’s Degree (or equivalent) in a related scientific discipline.
Higher degree (PhD) is an advantage.
Minimum of 5 years of regulatory experience in RA or related healthcare environment.
Experience working in a regulated environment.
Ability to work in a matrixed environment and manage multiple activities and priorities.
Strong scientific knowledge and ability to discuss technical matters with cross-functional teams.
Knowledge of regulations and the ability to apply and communicate them.
Ability to identify compliance risks and escalate when necessary.
Leadership, coaching, or mentoring skills.
Excellent verbal and written English communication skills for multi-location collaboration.
Strong teamwork and collaboration skills.
High attention to detail.
Reasonable Accommodations:
Baxter is committed to providing reasonable accommodations for individuals with disabilities. If you require an accommodation for any part of the application or interview process, please reach out using the provided link.
Recruitment Fraud Notice:
Be aware of fraudulent parties posing as Baxter recruiters. For protection tips, review Baxter's Recruitment Fraud Notice.
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