Sr Specialist - Regulatory Affairs

Zvh; Bengaluru; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Baxter in Bengaluru seeks an experienced Regulatory Affairs professional to provide regulatory support for on-market products, manage change assessment, variation planning and submission documentation. You will coordinate with global and regional teams to deliver timely regulatory deliverables and ensure compliance across product lifecycle.

The ideal candidate holds a Master’s degree in a scientific field, 7+ years in RA, strong knowledge of RIM systems and CTD Module 3, and excellent written

Qualifications

• Master's degree in a related scientific discipline. Higher degree/PhD is advantageous.
• 7+ years of regulatory experience in RA or healthcare.
• Experience with RIM systems and handling regulatory submissions.
• Experience with CMC regulatory authoring and CTD Module 3.
• Ability to work in a matrixed environment and meet deadlines.
• Strong verbal and written English communication, for multi-location collaboration.

Responsibilities

• Review regulatory impact assessments for changes.
• Support global submission deliverables for product variation submissions.
• Coordinate with Regulatory teams to achieve results.
• Execute global plans and deliverables for sustaining variations.
• Prepare submission deliverables to meet compliance requirements.
• Ensure regulatory content standards are met and respond to queries.
• Engage with Global and Regional Regulatory teams for alignment.
• Maintain regulatory files and track status and quality.

Skills

Regulatory impact assessment

Variation planning

CTD Module 3 knowledge

Regulatory submissions

Cross-functional collaboration

English communication

Attention to detail

Regulatory information management

Project coordination

Education

Master's Degree or country equivalent in related scientific discipline

PhD advantage

Tools

Regulatory Information Management (RIM) systems

CTD documentation tools

Job description

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride.

Your Role at Baxter:

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.

What you'll be doing:

• Review and provide regulatory impact assessments for changes
• Support global submission deliverables for product variation submissions
• Responsible for working with other parts of the regulatory organization to achieve desired results.
• Execute global plans and regulatory submission deliverables for sustaining variations
• Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results
• 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
• Tracking of status, quality/compliance and progress of regulatory documentation
• Review, edit and proofread regulatory documentation

What you'll bring:

• Master's Degree or country equivalent in related scientific discipline
• Higher degree/PhD will be an advantage, 7+ years' regulatory experience in RA or related healthcare environment
• Experience in Regulatory Information Management (RIM) systems, including managing regulatory data, submissions, registrations, and maintaining data quality and compliance.
• Experience in CMC regulatory authoring, including preparation and review of CTD Module 3 documentation and supporting global regulatory submissions throughout the product lifecycle.
• 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 escalation when necessary
• Excellent verbal and written English communication skills, suitable for multi-location working relationships
• Demonstrated teamwork and collaboration skills
• 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.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.