Regulatory Affairs Jobs | Baxter is Hiring | Life Sciences Eligible
Looking for impactful Regulatory Affairs Jobs in the pharmaceutical and healthcare industry? Baxter is hiring for the Specialist, RA position in Ahmedabad, Gujarat. This opportunity offers professionals the chance to work on pharmacovigilance activities, regulatory submissions, risk management plans, and global compliance projects. Candidates seeking a rewarding Baxter Career and long-term growth through Life Sciences Jobs should explore this exciting opening.
- Position: Specialist, RA
- Department: Regulatory Affairs
- Location: Ahmedabad, Gujarat, India
- Employment Type: Full-Time
- Req No.: 204717
About the Company
Baxter is a global healthcare company committed to improving patient outcomes and advancing healthcare delivery worldwide. Since its founding in 1931, the company has focused on developing innovative medical products, therapies, and healthcare solutions. Baxter operates across multiple countries and serves healthcare providers, hospitals, and patients globally. With a mission to save and sustain lives, the organization offers excellent career opportunities for professionals in regulatory affairs, life sciences, pharmacovigilance, and healthcare management.
Key Responsibilities
- Prepare, review, and coordinate submission of PSUR, PBRER, and PADER reports as per regulatory timelines.
- Provide pharmacovigilance support for new submissions and post-approval regulatory activities.
- Handle RFI evaluations, authoring support, scheduling, and submission activities.
- Coordinate with Regulatory Affairs and PV teams to ensure timely compliance submissions.
- Assist in the development and submission of Risk Management Plans (RMPs).
- Support preparation and submission of Core Data Sheets (CO/NCO) and related safety documents.
- Perform signal management activities, including safety signal assessment and tracking.
- Develop and update RSI, CCDS, and CCSI based on emerging safety data.
- Conduct periodic reviews and revisions of CCDS/CCSI documents.
- Support local product label updates based on safety-related revisions.
- Maintain and monitor the XEVMPD database and manage EV code generation/updates.
- Track EudraVigilance requirements and support product registration compliance.
- Monitor global generic labels using Fluxguard and ensure regulatory alignment.
Qualification
Graduation in Life Sciences and Related Fields
This opportunity is ideal for professionals seeking specialized Regulatory Affairs Jobs in the pharmaceutical and healthcare sector. The Specialist, RA position provides exposure to global pharmacovigilance systems, safety reporting, risk management, and compliance activities. Candidates interested in building a successful Baxter Career while advancing through impactful Life Sciences Jobs are encouraged to apply and take the next step in their professional journey.
