Specialist, Regulatory Affairs – Gurgaon, Haryana, India
Job Summary
Vantive is seeking a Regulatory Affairs Specialist to lead regulatory filings and lifecycle management for drugs and medical devices across India, Sri Lanka, Bangladesh, and Nepal. The role requires drafting and reviewing registration documents, ensuring compliance with regional guidelines, and collaborating with global regulatory teams to support market access and product lifecycle activities. This is a critical position supporting the company's growth in vital organ therapies.
Key Responsibilities
Draft, review, and submit regulatory filings for new registrations, re-registrations, and manufacturer transfers for India/Sri Lanka/Bangladesh/Nepal.
Handle query responses, corrections, and post-registration regulatory updates in compliance with applicable regulations.
Develop and implement regulatory strategies to optimize market access and compliance in assigned countries.
Conduct ongoing regulatory monitoring for approved products, ensuring documentation is updated and compliant.
Evaluate amendments or product changes and determine necessary regulatory actions.
Track and report project progress to ensure timely submission and approval.
Review and supervise team projects before regulatory authority submission.
Liaise with global regulatory teams to gather materials and address product-related queries.
Provide regulatory intelligence to internal teams, maintaining strong cross-functional collaboration.
Prepare and review product labels, SOPs, and other regulatory documentation.
Support preparation of technical presentations and meetings with health authorities.
Required Skills & Qualifications
Bachelor’s degree in Pharmacy, Life Sciences, or a related field.
Strong knowledge of regulatory frameworks for drugs and medical devices in India and neighboring markets (Sri Lanka, Bangladesh, Nepal).
Experience in drafting and submitting registration dossiers.
Familiarity with regional and global regulatory guidelines.
Ability to manage multiple projects with strict timelines.
Excellent communication and coordination skills.
Detail-oriented with strong organizational abilities.
Proficient in MS Office and regulatory documentation tools.
Perks & Benefits
Competitive base salary (Not Disclosed)
Group insurance coverage
Flexible benefits package
Annual leave and paid time off
Professional development opportunities
Company Description
Vantive is a global leader in vital organ therapy with 70+ years of innovation in kidney care and dialysis solutions. The company is committed to transforming patient outcomes through digital health technologies and advanced medical services, expanding its impact across Asia and beyond.
Work Mode
On-site – Gurgaon, Haryana, India
Call-to-Action
Ready to make a meaningful impact in the pharmaceutical regulatory field? Apply now to join Vantive as a Regulatory Affairs Specialist and shape the future of vital organ therapies in South Asia.
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