모집부문 및 자격요건

근무조건 및 환경

전형절차 및 제출서류

접수기간 및 방법

RESPONSIBILITIES & QUALFICATIONS

[Primary Responsibilities]

- Supports Labeling Managers by maintaining documentation in GDMS, PfLEET and other systems so that SOP requirements are fulfilled. Maintenance of workflow management tools and mailboxes.

- Ad hoc support for labeling deliverables.

- Proof-reading of labeling text

- System data integrity and quality checks

[Technical Skill Requirements]

- Has fundamental knowledge of the principles and concepts of labeling.

- Basic knowledge of key regulatory and labeling principles and local regulations

- Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining high compliance figures

- Fluency in English language important however multi-language skills are advantageous

- Clear and effective written and verbal communications

- Understanding of the importance of Standard Operating Procedures (SOPs), systems and processes in underpinning quality and compliance of deliverables

- Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access

[Qualifications (i.e., preferred education, experience, attributes)]

1. Education

- Life sciences, pharmacy graduate or equivalent

2. Experience

- ‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products); preferably from the perspective of a Country office or Regional Regulatory Strategy is advantageous especially with the perspective of the implications of a CDS on LPDs

- Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.

- Knowledge of global/regional regulatory guidelines and requirements is preferable

- Knowledge of Clinical Variations preferred

- Proven strength in logical, analytical and writing ability essential

- Demonstrated project management, attention to detail and problem solving skills required.

- 1~2 years of regulatory experience

- Pharmacist if preferred, but not mandatory