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Sr Specialist, Regulatory Affairs

2+ years
Not Disclosed
10 April 25, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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Job Title: Sr Specialist, Regulatory Affairs

Location: Bengaluru, Karnataka, India

Job Type: Full-time

Job ID: JR - 168420

 


Company Overview:

At Baxter, we are united by a mission to save and sustain lives. With over 85 years of innovation in healthcare, Baxter’s products and therapies are trusted in hospitals, clinics, and homes around the world. We foster a collaborative environment that inspires purpose, personal growth, and success. Join us where your work contributes directly to improving outcomes for millions of patients.

 


Job Description:

The Sr Specialist, Regulatory Affairs will be responsible for conducting regulatory intelligence surveillance, maintaining systems, and supporting strategic compliance activities. The role requires effective monitoring and dissemination of global regulatory updates, contributing to internal databases, and supporting Baxter’s regulatory strategy through timely and accurate intelligence.

 


Key Responsibilities:

 

  • Monitor global regulatory landscapes to identify key requirements impacting Baxter.

  • Conduct detailed research using regulatory intelligence data sources.

  • Compile, update, and maintain regulatory intelligence records and databases while driving continuous system improvements.

  • Maintain and track internal systems that monitor the status of regulatory intelligence actions, compliance, and advocacy targets.

  • Provide regulatory guidance to project teams and participate as an active team member.

  • Support product and project-specific intelligence activities including periodic reports, program updates, presentations, and newsletters.

  • Perform other duties as assigned in alignment with regulatory goals.

 


Qualifications:

 

  • Bachelor’s degree or equivalent in a scientific discipline.

  • Minimum of 2 years of regulatory or equivalent experience in pharmaceutical, medical device, CRO, or similar organization.

  • Experience in drug, biologics, and/or medical devices preferred.

  • Cross-region regulatory experience preferred.

  • Strong research and analytical skills with attention to detail.

  • Effective communication and collaboration skills across functional teams.