Regulatory Affairs Specialist | Regulatory Affairs Specialist (all gender)

Job Summary

This role is designed for a dedicated Regulatory Affairs Specialist responsible for managing the regulatory lifecycle of pharmaceuticals or medical devices within a leading global development service provider. Key daily tasks include the preparation, maintenance, and submission of critical regulatory documents such as eCTD, IMPD, CTA, Variations, and Renewals. The specialist will ensure compliance by reviewing and approving labeling, packaging, and product information, while strictly adhering to regulatory frameworks including EU MDR, IVDR, GMP, ISO 13485, and ICH Guidelines. Success requires close collaboration with regulatory authorities, Notified Bodies, and internal departments (QA, R&D, Clinical), as well as supporting audits and inspections. Candidates must possess a degree in Pharmacy or a comparable natural science field, coupled with at least three years of professional experience in Regulatory Affairs within the Pharma, Biotech, or MedTech sectors. The position offers a permanent contract, flexible working options, and career development support.