[한국화이자제약] Regulatory Affairs- Dossier 담당자 모집 (계약직)<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />

Position title: Global Dossier Specialist (RA-Dossier 담당자)

Key Responsibilities

Dossier development and publication

&#8226; Develop a clear understanding of filing requirements for a particular product / molecule based on detailed guidance provided by Regional Dossier Strategists; serve as a thought partner to Regional Dossier Strategists to test assumptions and offer alternative solutions where appropriate
&#8226; Identify the fastest way to compile “fit-for-purpose” dossiers, leveraging existing components (e.g., from previous filings of the same molecule in other countries) where possible
&#8226; Provide clear direction to partner on data needs and establish timeline and method of delivery
&#8226; Communicate dossier preparation timeline to Project Manager and Regional Dossier Strategists, and proactively update them on status of dossier
&#8226; Compile the dossier and coordinate this compilation process across multiple collaborators (e.g., Regional Dossier Strategists, In-Country Regulatory Liaisons, partner organizations)
&#8226; Review and assess dossier readiness for filing once it is complete
&#8226; Coordinate publishing of dossier with other WSRO lines
&#8226; Ensure that final published dossier is uploaded into appropriate Pfizer systems (e.g., GDMS)
&#8226; Manage preparation of Reference Safety Document for labeling for the assigned molecule
&#8226; Develop best-practices to improve process and increase speed of dossier production; work with Project Managers to share and institutionalize best practices across regions

Requirements

- BS is required to ensure appropriate scientific understanding.
- Equivalent relevant R&amp;D based regulatory or relevant drug development experience will be considered.

- Min. 2~3 yrs of relevant experience required
- Ability to effectively communicate with internal and external suppliers for the preparation and delivery of the expert documentation required for inclusion in the regulatory package.
- Ability to ensure that comprehensive and timely records of communications, country requirements and regulatory status, are maintained in the relevant internal systems.
- Ability to manage and organize a high workload, with competing priorities.
- Fluency in English.
- Must have proven adequate experience in managing regulatory process and registration aspects comparable to the role being recruited to
- Demonstrated ability to communicate effectively both verbally and in writing; to lead discussion to a consensus and drive decision making

제출서류:

영문 이력서, 자기소개서 (각종 증빙서류는 서류전형합격자에 한해 추후제출)

접수방법:

- 지원 사이트: http://pfizercareers.com/apply 를 통해 접수.
(Korea, Republic of 선택-> Job ID 967650 검색 -> 고유 계정 등록 -> 필수정보 입력 / 이력서, 자기소개서 파일 업로드 (MS Word/ PDF) -> 접수 완료)