Study Start Up Lead (SSUL)

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The Position

Affiliate: Roche Pharma Korea

Cluster: Product Development Global Clinical Operations (PDG)

Work location: Seoul, South Korea

Study Start Up Lead (SSUL)

We are looking for a Study Start Up Lead (SSUL) who will specialize in IND (Investigational New Drug) applications and overall regulatory strategy to lead our clinical trials into action.

The Role

As an SSUL specializing in IND and Regulatory submission, you will be the architect of our country-level start-up strategy. You won't just follow processes—you will optimize them. Your primary focus will be ensuring the efficient and compliant start up of Roche-sponsored trials by mastering the bridge between global strategy and local regulatory requirements.

Who You Are

You are a strategic thinker with a deep understanding of the Korean regulatory landscape. You excel in a cross-functional environment and are passionate about driving innovation in clinical trials.

Qualifications & Skills:

• Proven experience(5-10 years) in IND/Regulatory submissions within the pharmaceutical industry or a leading CRO.

• In-depth knowledge of local regulatory requirements (MFDS, GCP, etc.) and experience interacting with HA or Ethics Committees.

• A "Solution-Oriented" mindset: Ability to identify bottlenecks and proactively drive process improvements.

• Strong communication skills in both Korean and English to effectively collaborate with global stakeholders.

• Leadership through influence: Ability to lead cross-functional teams without formal authority.

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.

Process

서류 전형▶ 면접 전형 ▶ 종합 심사 ▶ 최종 합격

※ 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.