Sr Spec Quality & Regulatory Affairs

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou will find purpose and pride.

• Prepare and execute regulatory submissions renewals variations and lifecycle management activities for assigned pharmaceutical and medical device product portfolios in India while supporting regulatory activities for Bangladesh and Sri Lanka.
• Compile review and submit regulatory dossiers authority responses and supporting documentation in accordance with local regulatory requirements and established timelines.
• Support regulatory submissions authority queries approvals and post-approval activities with Indian health authorities including medical device pharmaceutical import and registration applications through applicable regulatory systems and portals such as SUGAM.
• Perform regulatory assessments of product manufacturing labeling artwork supplier and site changes to determine regulatory impact reporting requirements and submission strategies.
• Maintain product registrations and regulatory approvals by ensuring timely completion of renewals post-approval changes commitments regulatory notifications and lifecycle management activities.
• Monitor changes in regulatory requirements regulatory intelligence and industry trends and communicate relevant risks requirements and potential business impacts to internal stakeholders.
• Liaise with health authorities distributors license holders and external regulatory partners to support product registrations regulatory approvals regulatory queries and compliance activities.
• Review and support approval of product labeling artwork promotional materials and regulatory documentation to ensure compliance with applicable local regulations and Baxter requirements.
• Support health authority inspections regulatory audits recalls and responses to regulatory queries observations and commitments in collaboration with cross-functional stakeholders.
• Collaborate closely with Global Regulatory Affairs Quality Supply Chain Commercial Marketing Medical Affairs and external partners to support regulatory submissions product launches lifecycle management activities compliance initiatives supply continuity and business objectives.
• Other duties as assigned.

Education and/or Experience:

• Bachelors Degree in Pharmacy Life Sciences Biomedical Sciences Biotechnology Chemistry Regulatory Affairs or a related scientific discipline.
• Minimum 5 years of Regulatory Affairs experience within the pharmaceutical medical device biologics nutrition or healthcare industry including product registrations lifecycle management regulatory assessments and health authority interactions.
• Experience supporting regulatory activities in India and working with distributors license holders or regulatory partners across South Asia is preferred.
• Experience using Regulatory Information Management Systems (RIMS) TrackWise SUGAM and other regulatory management tools is preferred

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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