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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

Responsible for proceeding regulatory projects to obtain the most rapid and optimal registration of new products and indications and to support the maintenance of existing products under minimal supervision, audit findings, identify trends, and establish action plans as a regulatory representative.

[Strategy/Planning]

Gather, analyze and communicate internal and external regulatory intelligence.

Provide regulatory expertise and input into cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)

Develop innovative, risk-based registration plans and submissions strategies for Affiliate products with limited guidance from DRA Management.

Represent Affiliate Regulatory in cross-functional teams.

[Filings]

Adapt global product dossiers to local requirements.

Prepare and manage regulatory registration filings across product lifecycles: Communication with global for filing, submission & requirements (CPP, ToC, Bridging report, GMP inspection & documents, Sample).

Monitor and communicate all regulatory filings status and respond to internal and external questions, or other needs.

Ensure timely regulatory filings submissions and approvals.

Influence internal and external stakeholders for successful regulatory outcomes.

[Information and Documentation Management]

Manage affiliate regulatory activities on relevant Roche systems

[Regulatory Compliance]

Develop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards

Ensure regulatory inspection-readiness for the Affiliate, as per assigned responsibilities

Ensure regulatory compliance for product release to market according to marketing authorizations

Ensure that all the changes (CDS, TRIC) for responsible products are proceeded according to local SOP and avoid the non-compliance

Timely manage HA request within defined timeframe by HA: Renewal, Re-evaluation, Safety instruction, Patent, Orphan status, Barcode registration, etc.

Timely inform the relevant stakeholders of the approval

Ensure the Regulatory Affairs database is updated with regulatory activities, timelines and priorities as per the Regulatory Standards and ensure accuracy of the data (RIM, Local Tracking logs)

[Other]

Manage end-to-end local product packaging and labelling from a regulatory perspective

Where applicable, provide regulatory administrative support for local lot releases

Support local market access activities from a regulatory perspective

Maintain and promote professional and effective relationships with customers

Actively provide opinion to the upcoming regulatory changes

Ensure effective knowledge sharing within the team
Attend external seminars and workshops and share knowledge between team members

Who you are

Education: Bachelor’s degree or higher in Pharmacy, Biology, Chemistry, or a related field (Pharmacist licensure preferred).

Experience: Minimum of 5 years of progressive experience in Regulatory Affairs within the pharmaceutical industry.

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

Skills:
-.Proven excellence in documentation and strong attention to detail.
-.Exceptional communication, negotiation, and interpersonal skills.
-.Professional working proficiency in English (verbal and written)

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.