Description
Kymanox is seeking a Regulatory Affairs Specialist to support US and EU regulatory submissions, technical and regulatory reviews, regulatory authority meetings, submission readiness, regulatory strategy, eCTD publishing, and regulatory risk management for pharmaceutical, medical device, and combination product clients. The role requires 1–5+ years of relevant regulatory experience, knowledge of FDA, EMA, ICH, GMP, CTD, design controls, risk management, and related regulations, and offers medical, dental, and vision benefits.
