Responsibilities:

• Plan the design and execution of Regulatory Strategy and define key regulatory requirements for accelerating developments for clinical development towards marketing authorization, applying in-depth knowledge of regulatory requirements and guidelines, procedures, and agency precedents.
• Review scientific data and reports to draft the Clinical/Regulatory development plans for the intended indications in aligned with regulatory requirements, including gap analyses, protocol synopsis development, meetings with regulatory authorities, and other strategic deliverables
• Work with project teams to draft and review of regulatory documents, including special designation requests, briefing packages for meetings with regulatory agencies

·       May coordinate, manage and submit regulatory documents such as regulatory applications and other regulatory submissions for INDs / NDAs / BLAs etc. to the MFDS or other Regulatory Authorities.

• May facilitate regulatory meetings with Regulatory Authorities on behalf of clients in scientific advice meetings settings
• Provide expertise in strategic interpretation of relevant regulations, requirements, and guidances to develop regulatory strategies and sound regulatory submissions
• Monitor changes and evolution in the regulatory landscape for therapeutic products and/or diagnostics and maintain advanced knowledge of changing regulatory requirements
• Participate in internal business development meetings and provide input on project scope definition and proposal/statement of wor

Qualification :

• Master's/Bachelor's degree in biological or life sciences, pharmacy, medicine, or related fields. Advanced degree or Regulatory certification preferred

·       Minimum of 7 years of Regulatory Affairs experience or equivalent of regulatory drug development in the biotech/pharmaceutical industry required. ; Professional experience working at the Regulatory Authorities preferred.

• Extensive previous experience in Regulatory Affairs in clinical drug development and regulatory filings for drugs, preferably some experience in oncology

·       Experience in the preparation and submission of large, complex regulatory documentation to support health authorities review/approval procedures, post approval activities ; ideally from within a consultancy firms, healthcare authority with focus on regulatory affairs and clinical Assessment and Review.

• Experience with CMC documentation pertinent to various dosage forms and biological product is a plus.

• Extensive knowledge of regulatory requirements and understand current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business.
• Ability to plan, prioritize, and execute work and projects in a systematic and efficient manner
• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.

채용 정보 :

Ÿ   직책 및 직급: 직책 및 한글 직급 협의 후 결정 가능

Ÿ   급여 사항: 협의 후 결정 및 업계 최고 수준.

Ÿ   고용 형태: 정규직

채용 절차 :

Ÿ   전형방법: 1차 서류전형/2차 & 3차 면접전형

Ÿ   제출 서류: 한글 이력서/자기소개서, 영문 이력서/자기소개서

Ÿ   접수 방법: 온라인 지원, hr@medirama.co,kr  

Ÿ   채용 문의 : hr@medirama.co.kr

Ÿ   기간 : 2024년 9월 3일 – 2024년 9월 30일

기타 참고사항

Ÿ   면접은 서류전형 합격자에 개별 통지합니다.

Ÿ   제출하신 서류는 일체 반환하지 않습니다

Ÿ   입사지원서 내용에 허위사실이 판명될 경우 입사가 취소될 수 있습니다.

기타 문의 사항은 반드시 E-mail로 문의바랍니다