Regulatory Affairs Executive / Manager

Company Description Bio-State Consulting is a full-service regulatory and product development consulting firm specializing in in vitro diagnostics (IVDs) and medical devices for the Indian market. The firm partners with organizations of all sizes to help bring innovative, safe, and effective products from discovery through testing, nonclinical work, clinical trials, and regulatory approvals. Bio-State Consulting is recognized for its efficient, end-to-end approach to market entry, leveraging deep industry and agency experience. The team is committed to supporting a better future for the IVD and medical device industry by turning complex regulatory challenges into opportunities for improved outcomes for clients.
Regulatory Affairs Manager & Executive
Positions: Regulatory Affairs Manager / Executive
Experience: Manager – 3–5 years | Executive – 1–2 years
Department: Regulatory Affairs
Location: Noida
Job Responsibilities
Handle regulatory submissions, registrations, renewals, variations, and product approvals.
Prepare and review regulatory dossiers and required documentation.
Coordinate with QA, QC, R&D, Production, and other departments for regulatory requirements.
Prepare responses to regulatory queries and maintain regulatory correspondence.
Ensure compliance with applicable CDSCO/DCGI, State FDA, and other regulatory guidelines.
Maintain regulatory records, licenses, approvals, and submission trackers.
Monitor regulatory updates and ensure timely implementation of changes.
Support regulatory audits/inspections and post-approval activities.
Eligibility
B.Pharm / M.Pharm / relevant Life Science qualification.
Manager: 3–5 years of relevant Regulatory Affairs experience.
Executive: 1–2 years of relevant Regulatory Affairs experience.
Good documentation, communication, coordination, and analytical skills.
Pharmaceutical industry experience preferred.

Work arrangement
No