Specialist - Regulatory Affairs

Roles & Responsibilities
• Learn and follow Health Authority guidelines and local regulations for drugs, medical devices, cosmetics, and food/health supplements
• Compile, prepare, and submit regulatory dossiers to Health Authorities (online and offline)
• Track application status and follow up on dossiers, queries, and approvals
• Respond to regulatory queries and coordinate meetings with Health Authorities for resolution
• Represent clients for product registrations, audits, and FDA-related communications
• Ensure proper maintenance and safe custody of original regulatory documents and records
• Update internal regulatory documentation in line with current guidelines
• Coordinate with internal teams and ensure effective communication with Health Authorities
• Monitor project deliverables and ensure SOP compliance and updates
• Verify application status through FDA portals and in-person follow-ups

Qualifications
• Bachelor of Pharmacy (B.Pharm)

Experience
• Up to 7 years of experience in Regulatory Affairs
• Experience in regulatory submissions for drugs; exposure to cosmetics, medical devices, and food/health supplements preferred

Skills
• Knowledge of regulatory affairs and Health Authority submission processes
• Understanding of FDA regulations, registrations, and audits
• Strong documentation and coordination skills
• Knowledge of CorelDRAW, Adobe Photoshop, and project management tools (added advantage)
• Ability to work independently using a laptop
• Willingness to be based in or relocate to NPT
• Female candidates preferred

About the Company
Genedrift is a regulatory-focused organization providing end-to-end regulatory affairs and compliance support for pharmaceuticals, medical devices, cosmetics, and food/health supplements, working closely with Health Authorities to ensure timely approvals and adherence to local and international regulatory requirements.