Regulatory Affairs Senior Manager

求人詳細

Lead regulatory strategies and submissions for innovative oncology products in a dynamic and collaborative environment.

■About the company
Our client is a leading precision oncology company focused on conquering cancer globally through its proprietary blood tests, vast data sets, and advanced analytics. They leverage technology, clinical development, and regulatory expertise to drive commercial adoption and improve patient outcomes. The company fosters a collaborative and innovative work environment.

■Role & Responsibilities
You will be responsible for developing and implementing regulatory strategies for innovative oncology products in the Japanese market. You will lead cross-functional teams, manage submissions to the PMDA, and ensure compliance with all relevant regulations. This role offers the opportunity to significantly impact the lives of cancer patients and contribute to the growth of a leading precision oncology company.

■Main tasks include
・Lead the development and execution of regulatory strategies for new and existing products.
・Manage the preparation and submission of regulatory documents to the PMDA.
・Collaborate with cross-functional teams to ensure alignment on regulatory requirements.
・Monitor and interpret changes in regulatory landscape.
・Lead communication with PMDA/MHLW to ensure timely approvals.
・Identify and mitigate regulatory risks.

If you are interested in this exciting opportunity, apply now.
We look forward to hearing from you.
#LI-Hybrid

こんな方を求めています

経験・スキル

■Requirements
・Bachelor's degree or higher in life sciences, engineering, or a related field.
・8+ years of experience in regulatory affairs, with at least 3 years in IVD, genetic testing, precision medicine, or oncology.
・Proven experience in managing regulatory submissions to the PMDA.
・Strong understanding of Japanese regulatory requirements for medical devices and IVDs.
・Excellent communication skills in Japanese and English.
・Strong organizational and project management skills.
・Experience leading and mentoring teams.
・Experience with QMS and design control.
・Familiarity with genomic/molecular technologies.
・Experience negotiating with regulatory authorities.

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 800 〜 1,200万円

賞与

Included. Plus RSU

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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