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Project Manager I (Fsp)

3+ 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

 


Sr Specialist, Regulatory Affairs
Company: Baxter
Location: Bengaluru, Karnataka, India
Job Category: Regulatory Affairs
Job ID: JR-168420
Date Posted: 04/22/2025

Company Overview:
Baxter is a global healthcare leader committed to saving and sustaining lives. With a legacy of over 85 years of medical innovation, Baxter's products and therapies are present in hospitals, clinics, and homes worldwide. The organization fosters a purpose-driven environment where every role contributes to improving patient outcomes.

Position Summary:
The Senior Specialist, Regulatory Affairs will be responsible for managing regulatory intelligence surveillance and system operations. This includes monitoring global regulatory developments, maintaining internal systems and databases, and ensuring timely and effective dissemination of intelligence to guide compliance and strategy efforts across Baxter.

Key Responsibilities:

  • Monitor and analyze global regulatory landscapes to identify key changes relevant to Baxter.

  • Maintain awareness of evolving regulatory requirements and communicate timely updates to internal stakeholders.

  • Conduct detailed research on regulatory topics using validated data sources.

  • Develop, update, and continuously improve regulatory intelligence systems and databases.

  • Track and trend Baxter’s actions on regulatory intelligence, compliance initiatives, and advocacy programs.

  • Collaborate with cross-functional teams and provide regulatory guidance as needed.

  • Support intelligence activities for assigned product portfolios, including report generation, presentations, and newsletter creation.

Qualifications:

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

  • Minimum 2 years of experience in regulatory affairs or a related field within the pharmaceutical, medical device, CRO, or similar industry (Required).

  • Experience across multiple regions and in drug, biologics, or medical device regulatory frameworks (Preferred).

Additional Information:

  • Baxter is committed to providing reasonable accommodations for individuals with disabilities throughout the application and interview process.

  • Be aware of employment fraud. Review Baxter’s Recruitment Fraud Notice to protect your personal information.