RA Senior Specialist (Regulatory Affairs) Position at Baxter, Gurgaon
A rare chance has emerged for experienced professionals seeking Baxter Regulatory Affairs Jobs in Gurgaon. With a minimum of 5 years of experience in the pharmaceutical or medical device industry, candidates can apply for this pivotal role that promises to make a significant impact in healthcare delivery.
About Baxter
Baxter is a global healthcare company that focuses on saving and sustaining lives through innovative medical products and services. Operating in the pharmaceutical and medical device sectors, Baxter is committed to redefining healthcare delivery to ensure that every individual has the opportunity to live a healthy life. The company fosters a culture of collaboration, trust, and accountability, empowering employees to make a meaningful impact in their roles.
Company: Baxter
Location: Gurgaon, Haryana, India
Experience: Minimum 5 years of Regulatory Affairs experience within the pharmaceutical / medical device industry
Application Reference: JR-207680
Baxter Regulatory Affairs Jobs: Job Description
The Senior RA Specialist in Regulatory Affairs will be responsible for executing and maintaining Regulatory Affairs activities for Baxter’s pharmaceutical and medical device product portfolios across India. These Baxter Regulatory Affairs Jobs include supporting regulatory activities for Bangladesh and Sri Lanka under limited supervision, ensuring timely product approvals and continued market access.
Key Responsibilities
- Support product registrations, lifecycle management, renewals, variations, regulatory submissions, health authority interactions, and compliance activities.
- Collaborate with various departments including Regulatory Affairs, Quality, Commercial, and Supply Chain to achieve business objectives and ensure regulatory compliance.
- Prepare and execute regulatory submissions and lifecycle management activities for assigned product portfolios.
- Compile, review, and submit regulatory dossiers and authority responses in accordance with local regulatory requirements.
- Maintain product registrations and regulatory approvals, ensuring timely completion of renewals and post-approval changes.
- Monitor changes in regulatory requirements and communicate relevant risks and impacts to internal stakeholders.
- Liaise with health authorities and external regulatory partners to support product registrations and compliance activities.
- Review and support approval of product labeling, promotional materials, and regulatory documentation.
Eligibility for Baxter Regulatory Affairs Jobs
- Bachelor’s Degree in Pharmacy, Life Sciences, Biomedical Sciences, Biotechnology, Chemistry, Regulatory Affairs, or a related scientific discipline.
- Minimum 5 years of experience in Regulatory Affairs, including product registrations and health authority interactions.
- Strong knowledge of India and South Asia regulatory requirements.
- Excellent project management, communication, and stakeholder management skills.
- Experience with Regulatory Information Management Systems (RIMS) and other regulatory management tools is preferred.
How to Apply
Interested candidates can apply through the official Baxter Workday link: CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
Additional Information
Baxter is an equal opportunity employer and evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.
Conclusion
This position at Baxter presents an excellent opportunity for qualified candidates to contribute to impactful healthcare solutions. Baxter Regulatory Affairs Jobs offer eligible professionals a chance to support product approvals and continued market access. Interested individuals are encouraged to apply before the deadline to ensure their consideration for this vital role.
