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Baxter International Hiring Regulatory Affairs Specialist
Baxter International Inc.
Regulatory Affairs Specialist Openings | Baxter Ahmedabad
Apply for Regulatory Affairs Specialist role at Baxter, Ahmedabad. Open for qualified pharma professionals with experience in regulatory submissions.
Join Baxter, a global healthcare leader dedicated to saving and sustaining lives, as a Regulatory Affairs Specialist in Ahmedabad, Gujarat. This role offers a rewarding opportunity to contribute to the company’s mission of delivering innovative healthcare solutions worldwide. If you are passionate about ensuring compliance, managing regulatory submissions, and shaping the future of medical product approvals, Baxter invites you to make a meaningful impact.
At Baxter, every role carries purpose — advancing global health and improving lives through safe, high-quality healthcare innovations.
Company Overview
Baxter International Inc. is a global healthcare company founded in 1931, known for pioneering advancements in pharmaceuticals, biotechnology, and medical devices. With operations in over 100 countries, Baxter is committed to improving patient outcomes through cutting-edge research, innovation, and ethical practices. The company’s mission to Save and Sustain Lives reflects its unwavering commitment to healthcare excellence.
Working at Baxter means becoming part of a diverse team united by trust, collaboration, and courage, empowering every employee to create a lasting difference in patients’ lives worldwide.
Job Role & Responsibilities
As a Regulatory Affairs (RA) Specialist, you will play a vital role in ensuring timely regulatory submissions, maintaining compliance, and supporting new product launches. Your contributions will directly influence Baxter’s mission of delivering life-saving products to patients globally.
Key Responsibilities:
- Prepare, review, and file high-quality regulatory submissions in compliance with applicable laws and standards.
- Coordinate with cross-functional teams — including R&D, Manufacturing, QA/QC, Engineering, Marketing, and Compliance — to gather and validate documentation for submissions.
- Provide strategic regulatory guidance to internal teams for India and other regional operations.
- Liaise with regulatory authorities for submissions, clarifications, and follow-ups.
- Ensure timely filing and maintenance of dossiers and regulatory documentation.
- Support product development and launch activities by providing regulatory insights.
- Develop and enhance RA quality standards and procedures to ensure compliance.
- Maintain audit readiness and support inspections or audits as required.
Eligibility / Qualifications
Educational Qualification:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related fields.
Skills & Competencies:
- Strong understanding of drug regulatory frameworks, dossier preparation, and submission processes.
- Excellent communication, organizational, and documentation skills.
- Ability to work collaboratively across functions and manage multiple priorities.
- Knowledge of global regulatory standards (USFDA, EMA, CDSCO, WHO, etc.) preferred.
- Proficiency in MS Office tools and regulatory tracking systems.
Experience:
- Candidates with prior experience in Regulatory Affairs, particularly in pharmaceutical or medical device submissions, are preferred.
Location & Salary
- Location: Ahmedabad, Gujarat, India
- Address: Navratna Corporate Park, Tower A (Ground Floor) & Tower B (21st & 22nd Floors), Gujarat – 380058
- Salary: Competitive; based on qualifications and experience.
Application Process
Interested candidates can apply through the official Baxter Careers Portal.
Apply Now on Baxter Careers
Apply before October 31, 2025, to be considered for the current hiring cycle.
Why Join Baxter?
- Work with a globally recognized healthcare innovator with a legacy of over 90 years.
- Opportunity to shape regulatory strategies for life-saving medical products.
- Be part of a collaborative team driven by purpose, ethics, and innovation.
- Continuous learning, inclusive culture, and professional growth opportunities.
- Access to global exposure and a diverse, inclusive work environment.
FAQs
Q1: What qualifications are required for the Regulatory Affairs Specialist role at Baxter?
Candidates should possess a degree in Pharmacy, Life Sciences, or a related field with experience in regulatory submissions.
Q2: What are the main responsibilities of this position?
The role focuses on managing regulatory filings, coordinating with authorities, maintaining compliance, and supporting product launches.
Q3: Where is the job located?
The position is based at Baxter’s Ahmedabad, Gujarat facility.
Q4: Is this role suitable for freshers?
This position is primarily suited for professionals with prior experience in Regulatory Affairs, though motivated freshers with relevant internships may also be considered.
Q5: How can I apply?
Applications can be submitted via the official Baxter Careers Portal linked above.
Summary Table
| Category | Details |
|---|---|
| Company | Baxter International Inc. |
| Vacancies | Specialist – Regulatory Affairs |
| Required Education | B.Pharm, M.Pharm, Life Sciences, Biotechnology |
| Experience | Prior experience in Regulatory Affairs preferred |
To apply for this job please visit www.baxter.com.