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Affiliate: Roche Diagnostics Korea
Division: Regulatory Affairs & Quality Assurance
Work location: Seoul, South Korea
Position Summary
1. The Regulatory Affairs Specialist is responsible for IVD products registration timely per launch plan and maintains the marketed products according to regulatory compliance.
2. This role will assess regulations, guidance for impact on the business area.
3. The incumbent will call for strong communication and strategic skills and a high level of understanding how RA function impacts on customer / patient life.
4. The RA specialist will also be required to involve a complicated registration project not only new product registrations but also re-evaluation, renewals and family product license change management per Korea regulations with accurate, clear and concise regulatory documents.
Main Responsibilities
1. Regulatory Compliance
Crosscheck the promotional materials according to the local regulation & relevant internal SOPs.
Review clinical trial protocol according to the local regulation & relevant internal SOPs.
Apply local regulation, DQS, and internal SOPs to the daily work area.
Collaboration with QA. in comply with regulatory compliance and KGMP support
2. Product Registration / Pre-market Activities
Registration of IVD in a strategic way through MA, QA and Clin.Ops collaboration
Support protocol development for local clinical studies
Closely work with Global/APAC Regulatory organization and multiple stakeholders and provide regulatory requirements for product registration
3. Regulatory Monitoring & Advocacy
Monitor local & global regulatory information and analyze the business impact
Provide the regulatory information to internal stakeholders to support appropriate business action/decisions.
Support advocacy activities to reflect RDK voice for revision regulation & shaping a reasonable regulatory environment.
4. Risk Management for Business Continuity / Project & Change Management
Impact analysis on product or regulation change and take proper actions for change management
Manage the global/internal regulatory project for business support and regulatory compliance strategically
Take the initiative in change management
5. Handling Internal / External Counterparts Communication
Establish communication channel with health authority and notified bodies for acting as counterpart
Cooperate with colleagues (MKT, MA, Clin.Ops, DP&L, MSA, and global stakeholders) and external partner(e.g. pharmaceutical company, outsourcing company) to meet the needs for new products launching and marketed products revisions
Who you are
1. Education & Qualification
Bachelor’s degree or higher degree in life science, biological sciences and pharmacy
High level knowledge of MD / IVD Regulations or CLSI guideline
Preference of RA certification
2. Experience
Over 4 years experiences in Regulatory Affairs related to IVD, Pharmaceuticals, Medical devices, and/or Digital health
Experience reviewing clinical data or papers
3. Competencies
Good documentation and accuracy skills
Fluent English communication (verbal and writing skill)
Excellent analytical, solution oriented and problem solving skills
Strong planning, time management and organizing registration & license management skills
Excellent communication skills
Ability to work effectively with cross functions and open & growth mindset
Teamwork skills
*Position title can be determined according to the final candidates's experience based on the company policy
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.
※ 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 이후라도 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.
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