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Are you a Regulatory Affairs professional looking to make a meaningful impact? Baxter is hiring a Regulatory Affairs Specialist (Spec, RA) in Ahmedabad, Gujarat. This role offers an exciting opportunity to support global regulatory submissions (US/EU/ANZ/Canada), review technical documents, and contribute to high-quality product dossiers.
At Baxter, every colleague plays a role in saving and sustaining lives. If you’re passionate about pharmaceutical regulations, compliance, and dossier authoring, this role could be your next career move.
Key Responsibilities
As a Regulatory Affairs Specialist at Baxter, your responsibilities will include:
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- Supporting the RA team in US (ANDA/NDA), Canada (ANDS/NDS), EU/ANZ filings including MAA, renewals, variations, and ownership transfers.
- Reviewing technical documents such as specifications, stability protocols, development reports, and manufacturing records.
- Assisting senior RA professionals with dossier authoring and technical write-ups.
- Collaborating with internal and external teams for regulatory submissions in a timely manner.
- Maintaining RA records in RIMS tools and ensuring global compliance standards (Data Integrity, GQPs, E&C).
- Ensuring consistency, quality, and compliance in regulatory submissions.
- Sharing learnings and best practices across the RA team.
- Proactively identifying areas where senior support is required for complex regulatory issues.
Qualifications & Skills
To succeed in this role, candidates should have:
- A Bachelor’s or Master’s degree in Pharmacy, Science, or related discipline.
- 1–4 years of experience in Regulatory Affairs, preferably in pharma dossier preparation.
- Good understanding of ICH guidelines, FDA/EMA/Health Canada regulations.
- Strong document review and technical writing skills.
- Ability to work collaboratively within cross-functional global teams.
- Familiarity with RIMS tools and global regulatory databases.
Benefits of Working at Baxter
- Opportunity to contribute to a global mission-driven company.
- Exposure to international regulatory frameworks.
- Collaborative work culture with career growth opportunities.
- Competitive salary and employee benefits.
Application Process
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