Regulatory Submissions

We are seeking an experienced Regulatory Submissions professional to join a dynamic team in Seoul. This role offers an exciting opportunity to contribute to clinical trials and regulatory activities across South Korea and the APAC region.The position is open at two levels: Manager (Regulatory Submissions Manager) or Associate Director, based on the candidate’s experience and expertise.Key Responsibilities:Lead regulatory submissions for clinical trials, focusing on study start-up activities.Serve as the primary regulatory contact with local health authorities in South Korea.Coordinate regulatory submissions within South Korea and across the broader APAC region.Collaborate with internal and external teams to ensure timely and compliant submissions.Provide regulatory guidance and contribute to process improvements.Support inspection readiness and regulatory strategy.Requirements:Manager (RSM):Bachelor’s degree in a science-related field.Minimum 5 years experience in a CRO with hands-on regulatory submission experience, particularly in South Korea and APAC.Strong English communication skills (written and verbal).Based in Seoul; open to hybrid work arrangements after initial in-office training.Associate Director:Bachelor’s degree in a science-related field.Minimum 8 years experience, including leadership or Associate Director level roles.Strong experience in regional regulatory submissions across South Korea and APAC.Excellent English communication (written and verbal).Based in Seoul, with hybrid work flexibility after initial in-office period.