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Affiliate: Roche Pharma Korea
Cluster: Access & Policy
Work location: Seoul, South Korea
Your key responsibilities
The Regulatory Excellence Lead drives regulatory integrity and strategic execution within the Regulatory Compliance and Regulatory Affairs (RA) Practice.
This role is the Affiliate's center of excellence for Regulatory Quality, responsible for establishing, maintaining, and overseeing the local RA processes (SOPs) to guarantee compliance with local and global standards.
The Regulatory Excellence Lead contributes to and supports internal audits from Product Development Quality (PDQ) or Corporate, evaluates audit findings, identifies trends, and establishes action plans as a regulatory representative.
[Regulatory Compliance]
Establish, maintain, and continuously improve the local RA processes, systems, and related SOPs. Provide critical input to global procedures to ensure all regulatory processes (e.g., submission, change control) maintain the highest level of compliance with local regulations and internal standards.
Identify changes in local regulations, especially focusing on new and upcoming requirements. Analyze the business impact on Roche products and ensure the proper implementation of these changes by updating Local Procedures and Global Regulatory Databases (e.g., CRDB, PDRL/ERAS joint DB, National Specific Requirements DB).
Oversee and guarantee regulatory compliance across all activities, including providing quality oversight of RA Partner activities to ensure a high level of compliance and prevent non-compliance. Utilize global regulatory systems (e.g., RIM, SIRIUS, EPIC-RS) and other relevant tools to monitor and ensure the accuracy and integrity of critical data.
Support the implementation of the QMS for regulatory work, confirming all local procedural documents adhere to GCP/GVP and other compliance requirements.
Liaise with a regulatory audit, lead the readiness actions, collaborate closely with local quality responsible for the PDQ audits, and be aware of the global regulatory requirements and inspection methods.
[Regulatory Affairs]
Lead the development of innovative, risk-based registration and submission strategies for Affiliate products, providing expert regulatory input to critical cross-functional strategies (e.g., market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)
Take full accountability for complex regulatory registration filings across the product lifecycle. Direct and execute the preparation, submission, and timely approval of these filings, influencing internal and external stakeholders to ensure successful regulatory outcomes.
Serve as the role model for compliance execution in all RA activities, demonstrating adherence to internal SOPs and local requirements, thereby validating the effectiveness of the Compliance systems for the entire RA team and ensuring audit readiness.
Who you are
● Bachelor’s degree or above in Pharmacy, Biology, Chemistry or a related field.
● In-depth understanding and comprehensive knowledge of regulatory environments, local law (KPAL, ICH-GCP/KGCP, ICH-GVP/KGVP), global/local SOPs, key internal compliance requirements (including PDR/PTR standards), and local regulatory requirements.
● Strong strategic thinking ability with high analytical and clear/accurate communication skill.
● Partnerships with other functions and organizations internally and externally (pharmaceutical associations of KRPIA/Kobia and MFDS).
● Prior leadership and management experience within a multinational pharmaceutical company, demonstrating the ability to develop/implement regulatory action plans and lead complex regulatory projects (e.g., new drug applications).
● Strength in RA process management, compliance oversight, and process improvement
● Strength in agile working principles and methodologies
Submission
자유 양식의 국/영문 이력서 및 국/영문 자기소개서 (하나의 MS Word 혹은 PDF 파일로 제출)
※ 이력서 상단에 반드시 현재 연봉과 희망 연봉을 표기하시기 바랍니다. 누락 시 이력서가 검토되지 않습니다.
※ 이력서 내 이메일 주소와 서류전형 지원 사이트의 입력하시는 이메일 주소를 반드시 동일하게 작성해주시기 바랍니다.
※ 국가보훈대상 및 장애인은 관련 서류 제출시 관련 법규에 의거 우대합니다.
※ 이력서에 개인민감정보 (신체적 조건, 출신 지역, 혼인 여부, 가족관계 등)는 기재하지 말아주십시오.
※ 입사 지원 서류에 허위 사실이 발견될 경우, 채용 확정 이후 라도 채용이 취소될 수 있습니다.
Next step
서류 전형▶ 면접 전형 ▶ 종합 심사 ▶ 최종 합격 통지
※ 면접은 서류전형 합격자에 한해 개별 통보합니다.
※ 면접 일정 안내 및 조율을 위해 해외 번호(중국)로 연락이 갈 수 있는 점 미리 안내드립니다.
※채용이 유력한 후보자에 대해서 이력 검증 및 평판 조회, 건강검진 등의 종합심사를 진행하여 최종 합격자를 선정합니다.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.