At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Affiliate: Roche Diagnostics Korea

Division : Regulatory & Quality

Work location: Seoul, South Korea

Your key responsibilities (업무 내용)  :

Lead and manage the Regulatory Affairs (RA) team to support the Head of RA, QA in achieving regulatory strategic objectives.Ensure timely registration of new products to enable successful product launches, and maintain compliance of marketed products with applicable regulatory requirements.Support the Quality Assurance (QA) team in managing KGMP audits for new manufacturing sites, as well as routine KGMP accreditation renewals.Monitor, assess, and interpret changes in the regulatory environment, and take appropriate actions to ensure continuous compliance of the company’s product portfolio.Establish and maintain strong communication channels with the Ministry of Food and Drug Safety (MFDS) and other relevant government authorities and industry associations.Provide regulatory guidance and training to internal departments to support sound decision-making and ensure cross-functional understanding of regulatory requirements.Collaborate closely with QA teams to ensure alignment with regulatory compliance and quality standards throughout the product lifecycle.Collaborate closely with SMEs of each department & Global HQ / APAC for fast access​

Who you are (자격 요건) :

Bachelor’s degree or higher in a relevant field such as Pharmacy, Biology, Chemistry, Biomedical Engineering, or other related scientific disciplines
Strong understanding of regulatory environments and requirements of MFDS, EU, and US authorities
In-depth knowledge of Medical Device and IVD regulations, international standards (ISO, IEC, etc.), and CLSI guidelines
Over 10 years of relevant experience in Regulatory Affairs, particularly in IVDs, pharmaceuticals, and/or medical devices
People management experience preferred

Submission (제출 방법)

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.

Process

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.

Who we are

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.