Role Overview
As the Manager, Regulatory Affairs, you will lead the full lifecycle of clinical trial regulatory submissions in Korea. This includes planning, preparing, and managing submissions for new and ongoing studies, ensuring alignment with local regulatory requirements and company policies. You will serve as a key regulatory contact throughout the trial lifecycle, supporting compliance and timely approvals.
Key Responsibilities
- Oversee end-to-end regulatory processes for clinical trials in Korea, including initial applications, protocol and informed consent form amendments, and periodic reporting, through to study close-out.
- Collaborate with the designated importer to develop and maintain study-specific import license approvals, ensuring ongoing compliance.
- Ensure high-quality, timely submissions by monitoring adherence to SOPs, project timelines, and local regulatory standards.
- Support regulatory inspections and internal audits, representing the Regulatory Affairs function with accurate and complete documentation.
- Provide regular updates on regulatory status to internal stakeholders and external service providers.
- Participate in cross-functional project meetings to define submission strategies, timelines, and regulatory requirements.
- Maintain up-to-date regulatory intelligence and ensure accurate documentation in internal databases.
- Coordinate pre-submission discussions with regulatory authorities when necessary, working with regional and global teams.
- Issue clear guidance to team members on submission preparation, timeline estimates, and resolution of regulatory issues.
- Work closely with local and global colleagues—including project managers, start-up associates, vendors, and contracts teams—to meet regulatory milestones.
- Escalate risks and compliance gaps to leadership, along with proposed mitigation strategies.
- Manage and supervise the in-country Functional Service Provider (FSP), ensuring contract compliance and high-quality delivery of regulatory and safety filings.
Required Qualifications
- Bachelor’s degree in Pharmacy or a related health sciences field.
- 6–7 years of experience in clinical trials, with at least 3–4 years focused on regulatory submissions.
- Proven experience in preparing and managing Clinical Trial Applications in Korea.
- Strong understanding of Korean regulations for medicinal products and clinical research.
- Fluency in English, both written and verbal.
- Ability to develop and manage project timelines, delegate tasks, and make risk-informed decisions.
- Experience managing multiple priorities in a matrixed, global team environment.
- Strong interpersonal skills to build effective working relationships across departments and with external partners.
- Capacity to work independently and across time zones, with minimal oversight.
Preferred Qualifications
- Experience preparing for, attending, or responding to Good Clinical Practice (GCP) inspections.
