Sr Specialist - Regulatory Affairs

Baxter International Inc.; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Baxter International Inc. is seeking a Regulatory Affairs professional to provide regulatory support for on-market products and manage submissions across markets. You will work with cross-functional teams to plan variations, ensure compliance, and maintain robust regulatory documentation.

In this role, you will engage with Global and Regional Regulatory teams, execute global plans, and ensure alignment with business needs while upholding high standards of data quality and process excellence.

Qualifications

• Master's degree in a related scientific discipline is required.
• PhD is an advantage and 7+ years regulatory experience in RA or healthcare.
• Experience with RIM systems and data management.
• CMC regulatory writing including CTD Module 3.
• Experience in operating in a regulated environment.
• Ability to work in a matrixed organization with multiple priorities.
• Excellent English communication, both written and verbal.
• Proven teamwork and collaboration skills.
• Strong attention to detail in regulatory submissions.

Responsibilities

• Provide regulatory support for on-market products and changes.
• Contribute to global submission deliverables for variations and lifecycle management.
• Coordinate with Regulatory teams to align with business requirements.
• Prepare and review submission deliverables and maintain regulatory files.
• Track status and quality of regulatory documentation; respond to queries.

Skills

Regulatory knowledge

Cross-functional collaboration

Attention to detail

English communication

Education

Master's degree in related scientific field

PhD (advantage)

Tools

Regulatory Information Management (RIM) systems

CMC regulatory writing

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 elevate 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.

Recruitment Fraud Notice

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