RA Senior Specialist (Regulatory Affairs)
RA Senior Specialist (Regulatory Affairs)
Baxter
Job description
Company Description
Baxter is a healthcare company that was founded in 1931. Baxter’s mission is to save and keep lives safe. Baxter makes devices and drugs that help patients all over the world. Baxter’s culture is based on courage, trust, and teamwork. Baxter gives every employee a chance to make a difference. Baxter operates in many countries. Baxter keeps working to make healthcare better and easier for everyone.
Job Summary
This position belongs to the Regulatory Affairs team located in Gurgaon, India. As a Senior RA Specialist, you will handle activities for Baxter’s pharmaceutical and medical device products throughout India. The position also helps with work in Bangladesh and Sri Lanka. Manage product registrations, renewals and compliance tasks under supervision while coordinating with many internal teams.
Key Responsibilities
Manage product registrations, renewals, variations and lifecycle activities for the products assigned to.
Submit regulatory dossiers and all required documents by the deadlines.
Work closely with health authorities on submissions, queries, and approvals.
Use regulatory systems and portals, including SUGAM, for applications and updates.
Review product, label, artwork and manufacturing changes for regulatory implications.
Manage renewals, notifications and other vital lifecycle management tasks.
Keep me posted on any changes and inform my internal teams of any risks.
Work with distributors, licensees and external regulatory partners;
Review labels, artwork and promotional materials for compliance.
Assist with health authority inspections, audits, and recall activities.
Work with Quality, Supply Chain, Commercial and Global Regulatory teams on submissions and launches.
Educational Qualification and Skills Required
A Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, Chemistry or a related scientific field.
Have least five years of experience in Regulatory Affairs in pharma, medical devices or healthcare and Regulatory Affairs experience is essential.
Possess knowledge of India and South Asia regulatory requirements, including CDSCO and SUGAM.
Project management, communication and negotiation skills. Ability to manage multiple regulatory tasks and flag compliance risks early.
Expertise with South Asia regulatory partners or distributors is a plus.
Familiarity with RIMS, TrackWise, or SUGAM tools is preferred.
Salary Structure
The average salary of a Senior Regulatory Affairs Specialist at Baxter International in India typically ranges from ₹11.4 Lakhs to ₹16.3 Lakhs per year.
Career Development
This position gives experience with rules and laws in India and nearby areas. Baxter helps people grow over time with learning, guidance and clear ways to move into jobs related to rules and laws.
How to Apply
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Key Skills
Market insights & trends
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Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.