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]

English (Original) follows Japanese.
• アジアオセアニア地域における薬事申請戦略の策定,実装を主導します.新規申請から承認後のメンテナンスまでを担当します.
• 薬事担当者間で連携し,各国の規制要件の理解に基づき,アステラス製薬全体として最適な薬事戦略の策定に貢献します.
• 薬事申請戦略の策定にあたり,ステークホルダーに対して規制の確かな理解に基づいたガイダンスを提供し,最適なスケジュールを策定,実装,必要に応じてタイムラインの調整を行います.
• 関係者が適切な医薬品販売承認申請文書や照会事項への回答を作成できるように,薬事担当者として適切なサポートをします.
• 当局に提出するための薬事申請資料の作成を主導/調整し,販社やビジネス パートナーを通じて医薬品販売承認申請する責務があります.Module 1の専門的な内容の作成に加えて,提出用のフォーム,カバー レターなどの準備をサポートします.
• 必要に応じて,ビジネス パートナーや当局の審査官と専門的な関係を構築します.例えば,当局相談にて十分な議論をし,重要な結果や当局指示を得られるよう資料準備,会議,記録をサポートします.
• Internationalの地域間で当局申請に必要な文書の入手提供を行います.

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

*1 APAC: Asia Pacific
• 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 RA-TA*2, CMC-RA*3, Labelling and Affiliates / Business Partners, and/or other relevant functions as applicable.

*2 RA-TA: Regulatory Affairs Therapeutic Area

*3 CMC-RA: Chemistry, Manufacturing & Controls - Regulatory Affairs
• Coordinates and monitor timelines for the execution of the Content Planner.
• Contribute submission strategy setting for MAAs*4 and post-approval variations with robust knowledge on relevant regulations

*4 MAA: Marketing Authorization Application
• Support to create and complete local regulatory documents for various submissions including, but not limited to, MAAs*4 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*5 to align Astellas' regulatory strategies; influences internally and externally to contribute to project/product decision making ensuring viable regulatory approaches.

*5 GRET-REN: Internal RA meeting with global and regional stakeholders

[職務の内容 / Essential Job Responsibilities]

(雇入れ直後)

English (Original) follows Japanese.

1. このポジションは,医薬品のライセンス維持活動の治療領域に合わせて,International地域における製品開発および製品登録の"維持と拡大"を目的とした規制戦略の立案• 準備• 実行を主導します.

2. 戦略的および戦術的な計画の策定に向けて,専門的および規制上の知識に基づいて,社内グループ,関連会社,またはビジネス パートナーに積極的にガイダンスを提供します.

3. 医薬品販売承認申請とその承認,維持,修正,更新,変更,照会事項回答などに必要な申請文書の作成をサポートします.当局提出資料の作成計画の実行において,タイムラインの調整およびモニタリングを行います.

4. RA TA*1,CMC-RA*2,RA オペレーション,CCDS*3 ラベリングなど,アステラス製薬のAPAC地域や担当製品に関わる各部署と連携し,薬事戦略を立案します.

*1 RA-TA: Regulatory Affairs Therapeutic Area

*2 CMC-RA: Chemistry, Manufacturing & Controls - Regulatory Affairs

*3 CCDS: Company Core Data Sheet

5. APAC(Asia Pacific)地域の視点からの部門横断プロジェクトへの薬事の情報提供を行います.Project Management部門およびRegulatory Operations部門と積極的に連携し,APAC地域における様々な適応症および化合物の薬事申請について,適切な計画立案,計画管理,合意形成およびタイムラインの調整を行います.適切なプロジェクト管理ツールを用いて,最新情報を提供し,薬事申請のタイムラインを管理します.

6. 該当する場合: ビジネス パートナーのスタッフと専門的な関係を構築し,ビジネス パートナーと直接連携して当局との連絡窓口を司ります.また,当局相談にて十分な議論をし,重要な結果や当局指示を得られるよう,資料準備,会議の主導,記録をサポートします.

7. 規制/ガイダンス/通知の解釈など,アステラス製薬に関係する最新の規制およびガイダンスに関する知見を維持し,規制遵守を確実にするため,必要な関係者へ適切に周知/通知します.

8. 規制およびその他の会社全体および部門のポリシーと標準運用手順を立案,校閲,および維持します.

9. 該当する場合: APAC地域内でライセンス登録されているポートフォリオのプロモーション資材を確認し,承認します.

10. 該当する場合: Drug Safety teamsチームに規制に関する専門知識を提供します (例: PSUR*4 および PBRER*5 申請,リスク最小化計画の提出).

*4 PSUR: Periodic Safety Update Report

*5 Periodic Benefit-Risk Evaluation Report

11. 該当する場合:必要に応じて,サブリージョナルリーダーシップチームおよびその他のリーダー会のメンバーとして参加し,戦略および運用の観点で,患者の健康に影響を与える重要な解決策を提供し,アステラス製品の開発と持続的な成功をサポートし,貢献します.

12. 製品の変更管理の評価において CMC-RA*6 チームをサポートし,ローカル ポートフォリオに影響する変更について適切な申請計画と予想される審査タイムラインを定義します.

*6 CMC-RA: Chemistry, Manufacturing & Controls - Regulatory Affairs

13. 契約社員や販社を含むスタッフの監督と指導を行います.

14. RA-INT*7 内の他の地域の同僚と交流し,戦略の相乗効果をもたらします.

*7 RA-INT: Regulatory Affairs-International

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

*1 INTL: International Region

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*2.

*2 BP / BPs: Business Partner(s)

4. Collaborates with RA TA*1, CMC-RA*2, RA operation and CCDS*3 labelling on global/regional regulatory strategies and with Astellas functions for regional programs and products.

*3 RA-TA: Regulatory Affairs Therapeutic Area

*4 CMC-RA: Chemistry, Manufacturing & Controls - Regulatory Affairs

*5 CCDS: Company Core Data Sheet

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*6 and PBRER*7 applications, Risk Minimization Plans submissions).

*6 PSUR: Periodic Safety Update Report,

*7 Periodic Benefit-Risk Evaluation Report

11. If applicable: Participates as members 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*8 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.

*8 CMC-RA: Chemistry, Manufacturing & Controls - Regulatory Affairs

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

14. Interacts with peers in other regions within RA-INT*9 to ensure alignment of any synergy of strategies.

*9 RA-INT: Regulatory Affairs-International

(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>

English (Original) follows Japanese.
• 科学分野の学士号を必須とし,修士号以上が望ましい.
• 製薬会社での3˜5年の経験または同等の経験.
• 英語が堪能 (ビジネスレベル)
• 担当する国/地域の関連規制に関する深い知識.
• 化学/生物学/物理学に関する深い科学的知識と,その知識を規制に関わる課題や製品開発に応用する能力.医薬品開発の分野における専門家として認められている.
• 大規模/複雑なプロジェクトを管理し,必要に応じて直属の部下や部門内の同僚に規制に関するガイダンスやトレーニングを提供できる高い組織運営スキル.
• ステークホルダーとの連携を通じて,最小限の監督下でも適切に優先順位を判断し,複数業務を並行して遂行できる実証された能力.
• 優れた書面および口頭でのコミュニケーション能力,規制要件および基準を満たす文章作成能力.
• 異文化理解と文化的感受性をもって効果的にコミュニケーションし,効果的な業務関係を維持する能力.
• 専有情報や機密情報の取り扱いにおいて高い倫理観と誠実性を有する.
• 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."