Sr Specialist - Regulatory Affairs

Baxter Healthcare; Bengaluru; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Baxter Healthcare in Bengaluru, Karnataka, India, is seeking a Regulatory Affairs professional to provide regulatory support for on-market products, including change assessment, variation planning, submission documentation, and global regulatory submissions throughout the product lifecycle.

You will collaborate with Global and Regional Regulatory teams, prepare CTD Module 3 documents, manage regulatory data in RIM systems, and ensure compliance while maintaining high-quality submission

Qualifications

• 7+ years regulatory experience in RA or healthcare.
• Experience with Regulatory Information Management (RIM) systems.
• Experience in CMC regulatory authoring and CTD Module 3.

Responsibilities

• Provide regulatory support for on-market products and changes.
• Coordinate variation planning and submission documentation.
• Prepare and review CTD Module 3 documents.
• Engage with Global and Regional Regulatory teams to align with business needs.
• Maintain regulatory files and respond to queries in a timely manner.

Education

Master's degree in related scientific discipline

PhD preferred

Tools

RIM systems

Job description

This is whereyour 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.

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.

Prestige Shantiniketan, CR2, 9th Floor, Whitefield Main Road|Shantiniketan, CR4, 10th Floor, Whitefield Main Road|Karnataka- 560 048|Karnātaka|India