Description

General Information

Job Advert Title: Manager, RA Product Management APAC

Location: Nihonbashi, Tokyo

Division: Regulatory Affairs and Pharmacovigilance

Employment Class: Permanent

Description

[募集の背景 / Purpose & Scope]

This position leads development, preparation and implementation of regulatory strategies to maintain, and extend product development and registrations in the APAC-GCN region, in alignment with Therapeutic Areas for maintenance activities.

Provides proactive guidance to internal groups and affiliates or business partners based on technical and regulatory knowledge towards development of strategic and tactical plans.

Creates Content Planner and submission timelines for maintenance activities in collaboration with Therapeutic Areas, CMC-RA, Labelling and Affiliates / Business Partners, and/or other relevant functions as applicable.

Coordinates and monitor timelines for the execution of the Content Planner.

Contribute submission strategy setting for MAAs and post-approval variations with robust knowledge on relevant regulations

Support to create and complete local regulatory documents for various submissions including, but not limited to, MAAs and their maintenance, amendments, renewals, variations and deficiency letters, as well as the corresponding Content Planners, in addition to other relevant regulatory filings.

Directs affiliates and business partners and/or manages preparation of forms, cover letters or other administrative components for submissions in addition to non-admin. M1 content.

Specific responsibilities include leading/coordinating the generation and completion of regulatory documents for submissions to the corresponding health authorities and support of marketing application submissions through our affiliates and/or Business Partners.

Develops professional relationships with Business Partners and health authority staff whenever applicable; supports agency meeting preparation and facilitates key agency meetings to ensure full discussion of issues and opportunities; tracks key outcomes and commitments.

Ensure request document exchange across regions through Document Request Form.

Responsible for interacting with RA Therapeutic Area and RA representative through GRET-REN to align Astellas' regulatory strategies; influences internally and externally to contribute to project/product decision making ensuring viable regulatory approaches.

[職務の内容 / Essential Job Responsibilities]

(雇入れ直後)

1.This position leads development, preparation and implementation of regulatory strategies to maintain, and extend product development and registrations in the INTL-GCN region, in alignment with Therapeutic Areas for maintenance activities.

2.Provides proactive guidance to internal groups, affiliates and/or business partners based on technical and regulatory knowledge towards development of strategic and tactical plans throughout the lifecycle of the product.

3.Creates and completes local regulatory documents for various submissions including, but not limited to, MAAs and their maintenance, amendments, renewals and variations, and other relevant regulatory filings. Coordinates preparation of administrative documentation in close collaboration with affiliates and/or BP".

4.Collaborates with RA TA, CMC-RA, RA operation and CCDS labeling on global/regional regulatory strategies and with Astellas functions for regional programs and products.

5.Provides input for RA cross functional project from region. Actively works with project management and Regulatory Operations to ensure appropriate planning, tracking, and alignment of content and timelines for regulatory submissions across indications and compounds in the Region. Provides updates and manages assigned regulatory submission timelines using the appropriate project management tools.

6.If applicable: Develops professional relationships with Business Partners staff and acts as main contact with local regulatory agencies directly in coordination with Business Partners; supports agency meeting preparation, and key agency meetings to ensure full discussion of issues and opportunities and tracks key outcomes and commitments.

7.Provides guidance to all appropriate departments to ensure compliance with applicable regulations. Remains knowledgeable about current regulations and guidance, including interpretation of regulations/guidance and notification of appropriate Astellas personnel.

8.Develops, reviews and maintains regulatory and other company-wide and departmental policies and standard operating procedures.

9.If applicable: Reviews and approves promotional materials for assigned portfolios registered and promoted locally in the Sub-Region.

10.If applicable: Provides regulatory expertise to Drug Safety teams (e.g., PSUR and PBRER applications, Risk Minimization Plans submissions).

11.If applicable: Participates as member of the Sub-Regional Leadership team and other leadership committees, as appropriate, supporting and contributing to the development and sustained success of Astellas products that provide solutions that matter to the patient's health through excellence and leadership in strategic and operational competencies.

12.Supports CMC-RA team in the review of product Change Control and defines an appropriate submission plan and expected approval timeline for those changes that impact the local portfolio.

13.Supervises and coach staff, including contract support and affiliates.

14.Interacts with peers in other regions within RA-INT/GCN to ensure alignment any synergy of strategies.

(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 discipline required; advanced degree preferred.
• 3-5 years previous experience in pharmaceutical companies or equivalent.
• Fluent in English
• Strong knowledge on relevant regulations of covering countries/territories
• Strong scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development. Recognized as an expert in an aspect of pharmaceutical drug development.
• Strong organizational skills with the ability to manage large/complexed projects and provide regulatory guidance/training to direct reports and others in the department as needed.
• Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members.
• Excellent written and oral communication skills, with writing ability to meet regulatory requirements and standards.
• Ability to communicate effectively with cultural awareness and sensitivity and maintain effective working relationships.
• High integrity with respect to maintenance of proprietary, confidential information.

[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-jp.astellas.com/jp/recruit/newgraduates/

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."