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
Lead strategic regulatory initiatives and grow your career with a global leader in innovative pharmaceutical solutions.■About the companyOur client is a well-established international pharmaceutical company with a strong presence in Japan. They are dedicated to developing and delivering life-changing medications, fostering a collaborative and supportive work environment for their employees.■ Position OverviewYou will be responsible for developing and executing regulatory strategies for pharmaceutical devices in the Japanese market. You will collaborate with cross-functional teams, ensuring compliance and navigating complex regulatory landscapes. You'll lead the regulatory affairs function and build strong relationships with external stakeholders.■ Responsibilities* Lead the development and implementation of regulatory strategies for pharmaceutical devices.* Manage regulatory submissions and approvals for new and existing products.* Ensure compliance with all relevant Japanese regulatory requirements.* Collaborate with cross-functional teams to ensure timely product launches.* Build and maintain strong relationships with regulatory authorities.We are only able to accept applicants with valid permission to work in Japan and fluency in Japanese. Thank you for your kind understandingIf you are interested in this position, we look forward to your application.#LI-Hybrid#LI-KN

求められる経験
■ Requirements
* Minimum of 8 years of experience in regulatory affairs within the pharmaceutical industry in Japan.
* Extensive knowledge of Japanese pharmaceutical regulations and guidelines.
* Proven experience in leading regulatory strategies and submissions.
* Excellent communication and collaboration skills.
* Strong problem-solving and decision-making abilities.
* Business level or higher proficiency in both Japanese and English.
* Experience with regulatory affairs for medical devices is preferred.
* Bachelor's degree in a relevant scientific field is required.
* Advanced degree (Master's or PhD) is a plus.
* Experience working with global regulatory teams is a plus.

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700 ～ 1,380万円

賞与
-
雇用期間
期間の定めなし

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