Manager, Japan Regulatory Affairs Strategy @ Pharmaceutical Company

求人詳細

Lead strategic regulatory initiatives and grow your career with a global leader in innovative pharmaceutical solutions.

■About the company
Our 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 Overview
You 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 understanding

If you are interested in this position, we look forward to your application.

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こんな方を求めています

経験・スキル

■ 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.

学歴

大学卒業以上

募集要項

職種

薬事、メディカルライティング

給与

年収 700 〜 1,380万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

就業時間

09:00～18:00

休日休暇

土曜日　日曜日　祝日

保険

健康保険　厚生年金保険　雇用保険

受動喫煙防止措置

敷地内禁煙

業種

医療機器・医療品関連

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