【募集の背景 / Purpose & Scope】

Responsible for developing regulatory CMC strategy for assigned projects. Identifies and collects CMC data required for regulatory submission packages.

Plans and prepares CMC regulatory packages, assesses changes for potential regulatory impact, responds to action letters, and maintains filings and approvals.

Utilizes working knowledge of CMC to effectively interpret CMC development and changes and determine the impact on the project or product and the application.

Expected to support both development and commercial programs/products, end-to-end.

【職務の内容 / Essential Job Responsibilities】

(雇入れ直後)

・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 Astellas 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.

(変更の範囲)

会社内での全ての業務

【就業環境に関する要件 / Specific Physical or Environmental Requirements】

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home.

We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.

【応募要件 / Qualifications】

<必須 / Required>

・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 / Preferred>

・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.

【応募書類 / Application Documents】

和文履歴書・和文職務経歴書・英文レジュメ

Both Japanese and English Resumes are needed

【選考プロセス / Selection details】

書類選考 → 1次面接 →最終面接

※変更の可能性もございますので、予めご了承下さい。

CV screening → First interview → Final interview

Please be advised that there might be a change in the process.

【勤務地 / Location】

(雇入れ直後)

東京都中央区 アステラス製薬 日本橋事業所 本社

Nihonbashi, Tokyo

(変更の範囲)

会社の定める事業場および自宅

【勤務開始日 / Start Date】

応相談

Will be decided according to the candidate's flexibility

【契約期間 / Contract Duration】

期間の定めなし

Not limited to specified period

【試用期間 / Probation Period】

試用期間原則なし

No probation period in principle

【給与 / Salary】

①基本給:当人の経歴・技術・技能等を考慮して決定

②裁量労働制の場合:裁量労働手当として職務グレードに応じて50,000~100,000円支給

③フレックスタイム制の場合:月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給

①Base salary: will be decided by the candidate's experience, skill and capability.

②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000~100,000yen, based on the Grade)

③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.

【昇給 / Salary Raise】

有り

【賞与 / Bonus】

有り

【諸手当 / Allowance】

裁量労働手当、住宅手当、通勤手当 等

Discretionary work allowance, Housing allowance, Commutation allowance, etc.

【勤務時間 / Working Hours】

8:45~17:45(月~木)、8:45~16:00(金)、企画業務型 裁量労働制

裁量労働制の場合、所定労働時間を働いたものとみなす

8:45~17:45(Mon~Thu)、8:45~16:00(Fri)

Discretionary Work System

【休日 / Holidays】

完全週休2日制(土曜・日曜)、祝日、5月1日、夏季、年末年始

Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays

【休暇 / Vacation Leave】

年次有給休暇、育児休業制度、介護休業制度 等

Annual paid leave, childcare leave system, nursing care leave system, etc.

【福利厚生 / Welfare】

雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等

Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System

【アステラス製薬 採用サイト/ Career web site】


https:
//re-For more information about Astellas, please visit our career web site.

"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."

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