Gandiv Insights LLC · 8 hours ago
Regulatory Affairs Specialist
Raleigh, NC
Contract
Onsite
Entry, Mid Level
2+ years expGandiv Insights LLC is seeking a Regulatory Affairs Specialist to support regulatory submissions, lifecycle management, and compliance activities for pharmaceutical or medical device products. This role involves preparing regulatory documents and ensuring compliance within a fast-paced, GxP environment.
Information Technology & Services
Responsibilities
Prepare, review, and submit regulatory documents (IND, NDA, ANDA, BLA, 510(k), supplements, amendments)
Support regulatory strategy and product lifecycle management
Ensure compliance with FDA, ICH, and global regulatory requirements
Coordinate with cross-functional teams (QA, R&D, Clinical, Manufacturing)
Maintain regulatory files and submission trackers
Support audits, inspections, and health authority interactions
Qualification
Required
2–5+ years of Regulatory Affairs experience (Pharma, Biotech, or Medical Devices)
Strong knowledge of FDA regulations and submission processes
Experience with eCTD submissions and regulatory document management
Familiarity with GxP, ICH, ISO, and global regulations
Strong documentation, communication, and coordination skills
Company
Gandiv Insights LLC
Gandiv Insights is a leading professional services and staffing firm specializing in top-tier personnel and technical solutions across engineering, IT, non-IT, and healthcare sectors.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase