Job Description

社名
社名非公開

職種
薬事、メディカルライティング

業務内容
Contribute to the development and approval of innovative medical technologies that improve patient outcomes worldwide.
Work in a collaborative environment with opportunities for professional growth and advancement within the regulatory field.
Engage with diverse, cross-functional teams to navigate complex global regulatory landscapes and make a meaningful impact on public health.

求められる経験
Experience & Skills:
● A Bachelor’s degree in pharmacy, biology, chemistry, biochemistry, or a related field is required, with advanced education in regulatory affairs preferred but not mandatory.
● At least five years of experience in the pharmaceutical industry, preferably in regulatory affairs or quality assurance, with experience in government agencies or academic institutions being advantageous.
● Strong understanding of regulatory frameworks for pharmaceutical products, ideally with knowledge of Japanese regulatory requirements.
● Excellent written and verbal communication skills in both English and Japanese.
Ability to work independently while managing multiple tasks simultaneously.

● Detail-oriented with the ability to manage complex data sets and processes effectively.
● Proficiency in using computer systems and software applications commonly used in regulatory affairs, including document management tools.
● Knowledge of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).

保険
健康保険　厚生年金保険　雇用保険,健康保険,厚生年金保険,雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収900 ～ 1,100万円

賞与
Variable
雇用期間
期間の定めなし

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