Regulatory Affairs Partner

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.

Affiliate: Roche Pharma Korea

Cluster: Access & Policy

Work location: Seoul, South Korea

Position Summary

We are seeking a highly motivated and experienced Regulatory Affairs professional to lead the regulatory strategy and lifecycle management of our innovative pharmaceutical products in the local affiliate. This role requires strategic thinking, strong cross-functional leadership, and deep expertise in local regulatory requirements.

Your Key Responsibilities

1. Strategy & Regulatory Intelligence (Strategy/Planning)

• Provide expert regulatory guidance and input to cross-functional Affiliate strategies.

• Gather, analyze, and disseminate critical internal and external regulatory intelligence to key stakeholders.

• Develop and execute innovative, risk-based registration plans and submission strategies with limited guidance from management.

• Act as the Regulatory representative in cross-functional teams.

2. Submissions & Lifecycle Management (Filings)

• Lead the preparation, adaptation, and management of regulatory registration filings across the product lifecycle.

• Ensure timely submission and approval of all regulatory filings by coordinating closely with Global RA and regulatory authorities.

• Effectively influence internal and external stakeholders to achieve successful regulatory outcomes.

• Maintain up-to-date knowledge of local and international regulations to ensure affiliate-wide regulatory compliance (including inspection readiness and product release requirements).

• Ensure all product changes (CDS, TRIC) are processed according to local SOPs to maintain marketing authorization compliance.

• Manage the end-to-end regulatory aspects of local product packaging and labeling.

• Ensure the accuracy and completeness of regulatory activities and timelines in the Regulatory Affairs database (e.g., GPRS, local tracking logs).

 3. Compliance & Documentation (Regulatory Compliance)

• Maintain up-to-date knowledge of local and international regulations to ensure affiliate-wide regulatory compliance (including inspection readiness and product release requirements).

• Ensure all product changes (CDS, TRIC) are processed according to local SOPs to maintain marketing authorization compliance.

• Manage the end-to-end regulatory aspects of local product packaging and labeling.

• Ensure the accuracy and completeness of regulatory activities and timelines in the Regulatory Affairs database (e.g., GPRS, local tracking logs).

Qualifications

• Education: Bachelor's degree or higher in Pharmacy (Pharmacist qualification preferred).

• Experience: At least more than 5 years of progressive experience in Regulatory Affairs within the pharmaceutical industry.

• Knowledge: Comprehensive knowledge of the Pharmaceutical Affairs Act and MFDS regulations.

• Skills:

  • Demonstrated excellence in documentation and attention to detail.

  • Knowledge of Pharmaceutical Affairs Act and MFDS regulations.

  • Strong communication, negotiation, and influencing skills.

  • Fluency in English 

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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 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.