Sr Specialist - Regulatory Affairs

Baxter · Healthcare & Pharma

Bangalore, Karnataka
On-site
Posted today
Apply by 2 Nov
Healthcare & Life Sciences

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About the job

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 escalate 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.

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