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Specialist, Regulatory Affairs

2+ years
not specified
10 Sept. 3, 2025
Job Description
Job Type: Full Time Education: Not specified 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

Job Title: Specialist, Regulatory Affairs (RA)

Job Requisition Number: JR - 183209
Location: Ahmedabad, Gujarat, India
Department: Regulatory Affairs
Date Posted: 01/09/2025


About Baxter

At Baxter, we believe that every person deserves the chance to live a healthy life—regardless of background or location. Since 1931, this belief has guided our efforts to redefine healthcare and make meaningful, lasting impacts. Our colleagues are united by a culture of courage, trust, and collaboration, driven by our Mission to Save and Sustain Lives.

Join Baxter and find more than a job—find purpose and pride.


Position Summary

This position supports the Pharmaceutical Regulatory Affairs (RA) team by reviewing technical documents and providing assistance in drafting high-quality regulatory submissions for product dossiers in markets including US, EU, ANZ, and Canada. The role involves working collaboratively with internal teams under the supervision of senior RA members.


Key Responsibilities

  • Regulatory Support

    • Assist with regulatory filings such as ANDA/NDA (US), ANDS/NDS (Canada), and MRP/DCP/national registrations (EU, ANZ).

    • Support submissions for new MAAs, supplements, renewals, extensions, variations, and transfers of ownership.

  • Document Review & Authoring

    • Review technical documents, including:

      • Specifications

      • Methods of Analysis (MOA)

      • Stability Protocols

      • Product Development Reports

      • Batch Manufacturing Records

    • Assist with high-quality dossier authoring and technical write-ups.

  • Collaboration & Coordination

    • Work with internal/external stakeholders to collect, review, and finalize regulatory documents.

    • Ensure timely delivery of documents as per project timelines and quality standards.

  • Compliance & Standards

    • Ensure adherence to relevant guidelines such as Data Integrity, Ethics & Compliance (E&C), and Global Quality Policies (GQPs).

    • Apply relevant technical principles and regulatory knowledge in day-to-day work.

  • Database Maintenance & Documentation

    • Maintain regulatory data in RIMS tools for assigned franchises.

    • Ensure consistency and quality in scientific and administrative regulatory content.

  • Best Practices & Knowledge Sharing

    • Share learnings and best practices across teams regularly.

    • Escalate cases for additional support or guidance when needed.

    • Proactively contribute to Baxter’s regulatory compliance efforts.


Required Skills and Competencies

  • Understanding of regulatory processes for major global markets (US, EU, Canada, ANZ).

  • Ability to review and interpret scientific and technical documentation.

  • Familiarity with dossier preparation and regulatory submission requirements.

  • Strong communication, collaboration, and time management skills.

  • Ability to work independently under supervision and meet deadlines.


Work Environment

  • Location: Navratna Corporate Park, Ahmedabad

  • Exposure to a collaborative, fast-paced, and compliance-driven environment.

  • Part of a global team focused on high-quality pharmaceutical regulatory submissions.


Equal Opportunity Employment

Baxter is an equal opportunity employer. Qualified applicants are considered for employment without regard to:

  • Race

  • Color

  • Religion

  • Gender

  • Sexual orientation

  • Gender identity or expression

  • National origin

  • Age

  • Disability or veteran status


Reasonable Accommodations

Baxter is committed to providing reasonable accommodations for individuals with disabilities. If you require an accommodation during the application or interview process, click here to submit your request and contact details.


Recruitment Fraud Alert

Beware of employment scams. Baxter never requests financial or personal information via unauthorized channels. Review our Recruitment Fraud Notice to protect yourself.


How to Apply

Click on the "Apply Now" button on the job posting page.


Office Address

Baxter (India) Pvt. Ltd.
Navratna Corporate Park

  • Tower A, Ground Floor

  • Tower B, 21st and 22nd Floor
    Ahmedabad, Gujarat - 380058
    India