Regulatory Project Manager

募集要項

仕事内容

As a Regulatory Project Manager, you will:
・Facilitate project development as a Regulatory Project Manager and member of the Global Regulatory Project Team (GRPT), preparing strategic plans aligned with business demands.
・Provide regulatory intelligence, including updates on guidelines and regulations, to global and local team members.
・Submit high-quality applications for product authorization to achieve rapid approvals with targeted labeling and prepare documents for consultations and other regulatory submissions.
・Effectively interact with regulatory authorities to obtain and maintain marketing authorizations, optimizing the filing and approval processes.
・Coach and support team members in developing their competencies while collaborating with cross-functional teams to address project-related issues and enhance regulatory processes.

応募条件

【必須事項】

・Bachelor's degree or higher in a scientific field.
・Over 3 years of experience with the Japanese regulatory related processes in drug development, including familiarity with relevant regulations and basic scientific and medical knowledge related to the company's products.
・Strong leadership, planning, problem-solving, teamwork, and communication skills.
・Possesses a good business mindset, ethical behavior, an open mind, proactive attitude, adaptability to change, and a customer-oriented focus.
・Proficient in reading, writing, and speaking in both English and Japanese.

【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

転勤なし

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：129
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～1500万円　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

若干名

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