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
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
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Zaventem |Bosnia and Herzegovina :
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Sofia |Canada :
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Leinster | Remote - Europe | Tulsa | Castlebar | Green Way | Xzagreb | Ireland | Texas | Manipal | Medan | Remote - Middle East | Springville | Faridabad | Hungary | Slovakia | Belgium | Hammond | Minnesota | Bishop | Victoria | Remote - South America (Latin Americal) | Switzerland | Blue Bell | Remote | Thailand | Remote - Africa | Nairobi | Lousiana | French | McFarland | Melbourne | Bountiful | Lenexa | Riga | Remote, USA | Zaragoza |Bucharest :
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Rabigh | Najran | Jeddah | Riyadh | King Abdullah Economic City | Khulais |Nišava District :
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