CMC Expert

募集要項

仕事内容

・Prepare high-quality J-QOS documents, application sheets, and responses to inquiries from PMDA/MHLW in collaboration with Headquarters (HQ), while ensuring adherence to regulatory standards.
・Collaborate with HQ to discuss regulatory strategy and scientific considerations related to CMC application documents.
・Conduct reviews and quality control of M3 documents, J-QOS, and application materials prepared by HQ and local experts, supporting their accountability in compliance with regulations.
・Contribute to global CMC activities by sharing important Japanese regulatory information and insights from other drug development projects throughout various phases (development, submission, post-approval, and commercial).
・Engage effectively with regulatory authorities, external experts, and internal departments; provide coaching to CMC associates and RA staff to enhance their professional skills and knowledge.

応募条件

【必須事項】

The ideal candidate for the role should have substantial experience in drug development, including regulatory CMC knowledge and involvement in the approval of multiple product applications. Strong leadership, effective communication, a proactive mindset, and proficiency in both English and Fluency in Japanese are essential for success in this position. You will bring with you:

・Bachelor's degree or higher required, preferably in a medical science or chemistry field.
・+5 years of experience in drug development, including significant knowledge of regulations and pharmaceutical, chemical, or biological
・laboratory practices, as well as manufacturing processes. Experience in regulatory CMC and involvement in the approval of more than 5 product applications is preferred.
・Strong leadership capabilities, planning skills, problem-solving acumen, team spirit, and effective communication skills.
・A sound business mindset, ethical conduct, openness to new ideas, a proactive approach, readiness for change, and a customer-oriented attitude.
・Proficiency in reading, writing, and speaking English at a business level.

【歓迎経験】

【免許・資格】

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

6ヶ月

勤務地

転勤の有無

可能性あり

受動喫煙防止措置

屋内禁煙

勤務時間

フレックスタイム制
フルフレックス（コアタイムなし）

勤務開始日

応相談

休日休暇

年間休日数：122
土日祝
年間有給休暇：入社半年経過時点10日　10日 ～ 20日
法定休暇：年次有給休暇、産前産後休暇、介護休暇
その他休暇：ボランティア休暇、リフレッシュ休暇など

年収・給与

年収　　700万円～1100万円　経験により応相談

諸手当

通勤手当（全額支給）、時間外手当、住宅手当、その他各種手当有
MRの場合上記に加え、営業手当、外勤日当を支給

昇給

年1回

賞与

年2回

採用人数

1名　

待遇・福利厚生

通勤手当：有
確定拠出年金制度

各種制度

健康保険：有
雇用保険：有
労災保険：有
厚生年金：有

選考プロセス

１）書類選考
２）一次面接
３）二次面接
４）最終面接