Job Title: Specialist, Regulatory Affairs
Req #: JR – 171306
Location: Gurgaon, Haryana, India
Job Category: Regulatory Affairs
Date Posted: May 10, 2025
About Vantive
Vantive is a leading vital organ therapy company dedicated to extending lives and expanding possibilities for patients and healthcare teams worldwide. With a 70-year legacy in kidney care innovation, we are now broadening our impact by integrating digital solutions and advanced therapies to enhance patient outcomes.
Our mission is to provide greater flexibility, efficiency, and improved quality of life for patients undergoing vital organ treatments. At Vantive, we foster a culture of courageous innovation and relentless commitment to transforming healthcare.
Job Description
We are seeking a Regulatory Affairs Specialist to join our team in Gurgaon, Haryana. The ideal candidate will be responsible for managing regulatory submissions, compliance, and strategy for drugs and medical devices in India, Sri Lanka, Bangladesh, and Nepal.
Key Responsibilities:
✔ Prepare and submit regulatory filings for new registrations, re-registrations, and manufacturer transfers.
✔ Review and submit query responses, corrections, and post-approval notifications in compliance with local regulations.
✔ Develop and implement regulatory strategies to optimize business operations.
✔ Monitor regulatory compliance of approved products and ensure up-to-date documentation.
✔ Collaborate with global regulatory teams to gather necessary submission materials.
✔ Support regulatory intelligence efforts and maintain relationships with internal stakeholders.
✔ Assist in label reviews, SOP preparation, and departmental documentation.
✔ Track project progress and provide timely updates to relevant teams.
Qualifications & Skills:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field.
- Experience in regulatory affairs (drugs & medical devices) in India, Sri Lanka, Bangladesh, or Nepal markets.
- Strong knowledge of local regulatory guidelines and submission processes.
- Excellent communication and project management skills.
- Ability to work collaboratively with cross-functional teams.
Why Join Vantive?
✅ Impactful Work: Contribute to life-saving therapies.
✅ Innovative Culture: Be part of a forward-thinking healthcare leader.
✅ Career Growth: Opportunities for professional development.
✅ Global Exposure: Work with international regulatory teams.
How to Apply
Interested candidates can click the “Apply Now” button on the original job posting or visit the Vantive careers portal.
