Specialist, RA CMC Small Molecule

募集要項

仕事内容

・Acts as CMC regulatory lead or deputy for complex projects/products, requiring advice from manager on complex issues
・Manages technical documents for preparation, review and submission to regulatory agencies. Prepares INDs/CTAs & NDAs/MAAs, amendments & supplements, as well as responses to questions from regulatory agencies. Assesses scientific data against regulatory requirements and reviews submissions against regulatory strategy. Ensures proper CMC Dossier Management, including document version control.
・Ensures compilation and transmittal of submissions are within defined schedules and meet Health Authority and established standards/SOPs.
・Develops approach for new assignments having less-defined regulatory frameworks with management oversight.
・For assigned projects, monitors and facilitates resolution of CMC issues that have potential for regulatory impact.
・Regularly interacts with functional peer groups internally and externally, occasionally with senior management.
・Advises local teams on regulatory requirements. Interprets and ensures compliance with applicable Health Authority/ICH regulations.
・Stays informed of changes in Health Authority regulations and expectations, and shares lessons with others.


【Quantitative Dimensions】
・Maintains all assigned projects as compliant with regulations and guidelines. Addresses complex and diverse problems with decision making that impacts area of responsibility. Actively identifies, escalates and advocates for the optimal solution while informing the necessary audience of the benefits and drawbacks of each possibility.
・Interpreting regulations and guidance and the communication to QA and the project teams. Balancing multiple projects with conflicting timelines. Developing familiarity with all aspects of drug development. Maintaining working relationship with Health Authorities while still promoting the company position.

応募条件

【必須事項】

・Bachelor’s degree in scientific or related discipline.
・At least six years previous industry experience; three years in RA.
・Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development.
・Experience/expertise in an aspect of pharmaceutical drug development.
・Knowledge of Health Authority and ICH regulations and guidelines, and the ability to provide interpretations of that information to others.
・Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to others in the department as needed.
・Proven ability to prioritize and multi-task with minimal supervision based on interactions with project ream members.
・Effective written and oral communication skills, with writing ability to meet regulatory requirements and standards.
・Ability to communicate effectively and maintain effective working relationships. Must be able to positively influence department staff and other Astellas groups.
・High integrity with respect to maintenance of proprietary, confidential information.

【歓迎経験】

・Advanced academic degree (Ph.D. or Pharm.D.), with extensive (5+ years) and relevant experience in product development in the manufacturing or regulatory field.
・Advanced, interpersonal written and oral communication skills; advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment; able to manage complex projects by exercising independent decision making and analytical thinking skills; knowledge/experience of Health Authority regulations, guidelines and regulatory processes for NCEs, NBEs and product life cycle maintenance; ability to work in cross-functional and international environment; detail- and goal-oriented, quality conscientious, and customer-focused; ability to adhere to strict project timelines; strong team player; good judgment and problem solving skills, with ability to identify, analyse, and resolve problems in a timely manner; fluent written and spoken English and Japanese is required.
・Additional experience beyond small molecules, such as biologics, vaccines, cell/gene therapy or medical devices might be a preference.

【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

3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）
本社：8:45～17:45（月～木）、8:45～16:00（金）

勤務開始日

応相談

休日休暇

完全週休2日制
年間有給休暇：　
法定休暇：年次有給休暇、産前産後休暇、介護休暇
特別休暇：夏季休暇、年末年始休暇
その他休暇：祝日、5月1日　育児休業制度

年収・給与

年収　　600万円～1100万円　経験により応相談

諸手当

裁量労働手当、住宅手当、通勤手当　等

昇給

あり

賞与

あり

採用人数

1名　

待遇・福利厚生

通勤手当：有
寮・社宅：有
住宅手当：有

各種制度

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）適性検査
４）最終面接