Associate Director, Regulatory Affairs CMC Japan
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Monthly Salary:
Posted on:
5 days ago
Vacancies:
1 Vacancy
Job Summary
Position Summary:
ultrafocused Work together to fearlessly uncover new possibilities
TheAssociateDirector of Regulatory CMC willlead and executerelated chemistry manufacturing and controls (CMC) regulatory activities/interactionsunderoverall direction ofHead of Regulatory Affairs Japan and/orVP Global Regulatory CMCand will help to develop regional regulatory CMC strategies for both established products and development products serving as a key operational interface with global and regional teams.
Work Model:
Flex: This role will typically require onsite work 2-3 days each week or more depending on business many locations the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
- Contribute to thedevelopment andexecutionofthe CMC regulatory strategies andleadday-to-daymanagement ofrelated regulatory activities for assigned the guidanceof theHead of Regulatory Affairs Japan and/or VP Global Regulatory CMCwork with global and regional teams todevelop andmaintainproject plans and timelines for pipeline of products including coordination andsupportof global regulatory CMC submissions.
- Providefunctional supervision and guidance to team membersto ensure that all reporting requirements and other commitments are met with respect to Clinical Trial Notifications (CTN) NDAs PCAs MCNs etc.while escalating issues and risks to the Head of Regulatory Affairs Japan and/or VP Global Regulatory CMCas appropriate.
- Provide regulatory advice and supportforthe global regulatory compliance of Ultragenyx pipeline of products including the evaluation of CMC related change controls the strategic assessment of process and product comparability their regulatory impact and implementationwith escalation of key risks and issues tothe Head of Regulatory Affairs Japan and/or VP Global Regulatory CMCas appropriate.
- Coordinatethe preparation review and filing of CMC sections of regulatory submissions andsupportinteractions with regional regulatory agencies.
- Coordinate and oversee the preparation of regulatory CMC submission documentationto ensure that itis prepared withappropriatequalityandwithinagreedtimelinesinordertomeet regional regulatory requirements and corporateobjectives.
- Maintainand managea centralized archive for tracking andmonitoringthe status of regulatory CMC commitments and agency reporting obligations andpreparegenerateandcommunicatestatus reports and other communication to the organization.
- Provide strategicand technicalCMC regulatory supportguidanceandexpertise andserveas the Regulatory Affairs Japan point of contactfor CMC mattersto global and cross-functional teams including Pharmaceutical Development Quality Assurance Quality Control Manufacturing contractorganizationsand consultants. Ensurein alignment with the global regulatory strategy and under the guidance ofthe Head of Regulatory Affairs Japan and/or VP Global RegulatoryCMCthat all applicable regulatory requirements/options and associated risksare considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines.
- Provide guidance and advice on regulatory CMC environments; provide assessment of the impact of new and changing regulations/requirements.
Requirements:
- BA/BS in a scientific field of study with8years of relevant experience working in Regulatory in the pharmaceutical/ biotech industry.
- Strong knowledgeexperienceandthe ability toprovidetechnical guidancein interpretation of regulations and guidelines related to biological drugs and regenerative medicinal products development.
- Proven ability to analyze and organize information logically.
- Sound understandingandpracticalapplication of industry standards and international regulations and guidelines.
- Experience inclearly and effectivelycommunicating regulatorystrategiessubmissiondocuments and plans both internally and externally.
- The ability toeffectivelycoordinatemanageand prioritize multiple projects in a fast-paceddeadline drivenstart-up environment.
- Strong collaboration teamwork organizational skills at attention to detail
- Excellent written and verbal English and Japanese communication skills.
#LI-CK1 #LI-Hybrid
Position Summary:
ultrafocused Work together to fearlessly uncover new possibilities
AssociateDirector of Regulatory CMCJapanはHead of Regulatory Affairs Japan及びあるいはGlobal Regulatory CMCの指示に基づいて化学製造および管理CMCに関連する薬事業務および当局対応をリードし実行するグローバルチームおよび地域チームとの主要な業務インターフェースとしての役割を果たしながら既存製品および開発製品の双方について地域の薬事CMC戦略の策定を支援します
Work Model:
Flex: This role will typically require onsite work 2-3 days each week or more depending on business many locations the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
- 担当プログラムにおけるCMC薬事戦略の立案及び実行に貢献し関連する薬事業務の日常的な推進を主導しますグローバルおよび地域チームと連携し製品パイプラインのプロジェクト計画およびタイムラインを策定維持するとともにグローバルの薬事CMC申請の調整および実務的な支援を行います
- Clinical TrialNotificationsCTN新薬承認申請NDA承認事項一部変更承認申請PCA軽微変更届MCNなどに関する報告要件およびその他のコミットメントがすべて満たされるよう他のメンバーに対して機能的な指導管理を行い指導管理を行い必要に応じて課題やリスクをHead of Regulatory Affairs Japan及びあるいはVPGlobal Regulatory CMCにエスカレーションします
- Ultragenyxの製品パイプラインに関するグローバル薬事コンプライアンスについて助言および実務的な支援を提供しCMC関連の変更管理の評価プロセスおよび製品の同等性に関する戦略的評価それらの規制上の影響評価および対応の実行支援を行います重要なリスクや課題については適切にHead of Regulatory Affairs Japan及びあるいはVPGlobal Regulatory CMCへエスカレーションします
- 規制当局への申請に必要なCMC関連文書の作成レビューおよび提出を調整し地域の規制当局との対応を実務的に支援します
- 地域の規制要件および企業目標を満たすためCMC関連の薬事申請文書が適切な品質を確保し合意された期限内に準備されるよう管理調整を行います
- CMC薬事コミットメントおよび当局への報告義務の状況を追跡監視するための集中した文書管理を維持管理するとともに定められたプロセスに従い状況報告やその他の情報を作成発信し関連組織に共有します
- 製剤開発品質保証QA品質管理QC製造外部委託機関やコンサルタントなどグローバルおよび各機能横断チームに対しCMC薬事に関する戦略的かつ技術的なサポート指針および専門知識を提供しCMC領域におけるRegulatory Affairs Japanの窓口として対応しますまたグローバル薬事戦略に整合しHead of Regulatory Affairs Japan及びあるいはVP Global Regulatory CMCのガイダンスのもと適用される規制要件や選択肢および関連リスクを十分に考慮したうえで開発プログラムに適切に反映し製品が適切な規制やガイドラインに準拠して開発製造されるよう確保します
- CMCの規制環境に関して指針や助言を提供し新しい規制や要件の変更が与える影響を評価します
Requirements:
- 科学系分野の学士号BA/BSを取得しており製薬バイオテク業界における薬事関連業務で8年以上の実務経験を有すること
- バイオ医薬品および再生医療等製品の開発に関する規制ガイドラインの解釈について高度な知識経験を有し技術的な指針や助言を提供できる能力を持つこと
- 情報を論理的に分析し体系的に整理できる能力を有すること
- 産業基準および国際的な規制ガイドラインについて十分な理解を有し実務に適切に適用できること
- 規制戦略申請文書計画内容を社内外の関係者に分かりやすく効果的に伝えた経験があること
- 迅速で期限重視のスタートアップ環境において複数プロジェクトを効果的に調整管理し適切に優先順位をつけて遂行できる能力を有すること
- 高い協働性チームワーク組織力および細部への注意力を有すること
- 優れた英語および日本語の文書口頭コミュニケーション能力を有すること
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity/expression national origin/ancestry age disability marital and veteran status and any other status or classification protected by applicable federal state and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law including individuals with disabilities disabled veterans for pregnancy childbirth and related medical conditions and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or in any part of the recruitment process you may contact Talent Acquisition by emailing us at .
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Required Experience:
Director
About Company
Ultragenyx is focused on developing first-ever approved treatments for rare and ultrarare diseases and moving the rare disease community forward.
