Site Name: Korea - Seoul Posted Date: Jan 24 2025 Job Purpose Manages all aspects of long-term and/or multi-center regulatory research projects, including planning, coordination, execution, outsourcing, and risk management, ensuring compliance with written standards, local legislation, licensing conditions, and regulatory requirements. Key Responsibilities Responsible for overseeing regulatory commitment studies, ensuring full compliance throughout the project lifecycle, including data collection, analysis, and report writing, in accordance with regulatory requirements. Ability to develop and manage key study documents, ensuring alignment with scientific evidence and compliance with written standards and mandatory regulations. Take business ownership of relevant vendors, conducting oversight and risk management in alignment with GSK’s Internal Control Framework (ICF). Collaborate effectively with team members and key stakeholders to ensure successful project execution. Perform any other assignments as directed Requirements BS in science or related field (Pharmacy, nursing, biology, epidemiology, life sciences) 6~8 years related experience (Study project management Protocol, CRF, SAP development, CRO outsourced resource & contract management from vender assessment to execution, Budget projection & finance management, MFDS engagement, Hospital/clinical experience, Audit and clinical quality) Experience working in the pharmaceutical industry, collaborating with operational teams to better understand requirements and applying solutions efficiently. Maintain a high level of integrity while managing multiple priorities and responsibilities with a strong attention to detail and strategic organizational skills. Focused on solution-oriented thinking, agile in adapting to new systems and processes, and motivated to work with new applications and business processes. Demonstrate excellent verbal and written communication skills, with the ability to engage effectively with all levels both internally and externally, and the ability to write clear technical documentation required by regulatory agency (MFDS) in accordance with internal policies and national legislation. Demonstrate a strong commitment to accuracy, quality, and meeting goals or deadlines, with a sense of urgency, flexibility, and accountability. Must be a committed active team player, prepared to work in and embrace a collaborative, team-based culture, while providing expertise to train site personnel. Experience as the first author or co-author in research papers is highly valued. Include citation links to relevant publications in your CV Native Korean/business level of English *LI-GSK Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.