Regulatory Operations - Group Lead/Senior Group Direttore — Roche
- Località
- Basel
- Contratto
- full-time
- Pubblicato
- Ieri
Panoramica
At Roche you can show up as yourself, embraced for the unique qualities you bring.
Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.
- At Roche you can show up as yourself, embraced for the unique qualities you bring.
- Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
- The key responsibilities are structured around five core operational capabilities and comprehensive enterprise people leadership，responsible for: Content Strategy & Global Alignment:
- Lead data & content strategists to drive cross-functional teams in setting, executing, and optimizing the end-to-end regulatory content strategies for filings, partner with key stakeholders;
Responsabilità principali
- The key responsibilities are structured around five core operational capabilities and comprehensive enterprise people leadership，responsible for: Content Strategy & Global Alignment:
- Lead data & content strategists to drive cross-functional teams in setting, executing, and optimizing the end-to-end regulatory content strategies for filings, partner with key stakeholders;
- Submissions Management & Digital Innovation:
Processo di candidatura
- Drive the planning, coordination, compilation, publishing and submission of China/global regulatory applications (e.g., eSub, eCTD) ; provide technical expertise and guidance on Regulatory Information Management systems (RIM), eCTD specifications, and drive adoption of next-generation digital tools, automation, and AI/ML applications. Quality, Compliance & Crisis Readiness:
- Sustain and mature Quality and Compliance capabilities across the function in partnership with local Q&C communities, global compliance networks, and the Quality Management System (QMS).
- Oversee deviation management, audit and inspection readiness (including direct support for crisis management, GCP/GVP compliance, and Business Continuity Management).
- China Filing Team Project Management (CFTPM):
- Maintain the cFTPM resources and capabilities to drive and oversee the implementation of China filing strategies into a feasible NDA/BLA plan.
- Accelerate decision-making, optimize cross-functional collaboration, and break down departmental barriers.
- General Business Operations & System Evolution:
- Oversee team members to handle daily operational activities in a timely manner, including RegIM/RIM systems information archiving, tracking, searching, Power of Attorney (PoA), as well as response to various requests from internal/ external stakeholders, while continuously driving process efficiency and system enhancement.
Dettagli ulteriori
- Join Roche, where every voice matters. The Regulatory Operations
- The key responsibilities are structured around five core operational capabilities and comprehensive enterprise people leadership，responsible for: Content Strategy & Global Alignment:
- Drive the planning, coordination, compilation, publishing and submission of China/global regulatory applications (e.g., eSub, eCTD) ; provide technical expertise and guidance on Regulatory Information Management systems (RIM), eCTD specifications, and drive adoption of next-generation digital tools, automation, and AI/ML applications. Quality, Compliance & Crisis Readiness:
- Proactively manage RO team capacity, prioritize submission, publishing, documentation and cFTPM resources across competing TA timelines, and establish robust operational frameworks, prioritization criteria, and capacity allocation guidelines to support pipeline demands.. People Leadership & Talent Development:
- Performance & Development: Continuously assess performance based on impact rather than activity; actively develop internal talent and pipeline.
Note e contenuto originale
- Join Roche, where every voice matters.
- The Position
- The Opportunity
- The Regulatory Operations
- The key responsibilities are structured around five core operational capabilities and comprehensive enterprise people leadership，responsible for:
- Content Strategy & Global Alignment:
- Drive the planning, coordination, compilation, publishing and submission of China/global regulatory applications (e.g., eSub, eCTD) ; provide technical expertise and guidance on Regulatory Information Management systems (RIM), eCTD specifications, and drive adoption of next-generation digital tools, automation, and AI/ML applications.
- Quality, Compliance & Crisis Readiness:
- People Leadership & Talent Development:
Domande frequenti su questo annuncio
Che stipendio offre Roche per questa posizione?
Roche indica CHF 123'000 - 165'500 lordi annui per questo ruolo a Basel. Questo è lo stipendio pubblicato nell'annuncio originale (o, quando il datore non specifica una cifra, una stima realistica per ruolo e settore) — il calcolatore di questo sito lo converte nel netto reale una volta applicate imposta da frontaliere e contributi sociali.
È un ruolo a tempo pieno, e che tipo di contratto offre Roche?
Questo annuncio è una posizione a tempo pieno. Il tipo di contratto mostrato qui arriva direttamente dall'annuncio originale del datore di lavoro; conferma sempre orario esatto, preavviso e durata del periodo di prova con Roche durante il colloquio, perché questi dettagli possono variare anche all'interno della stessa categoria contrattuale.
Serve un permesso da frontaliere per un ruolo nel canton Basilea?
I residenti UE/AELS nella zona di frontiera del paese confinante con il canton Basilea possono richiedere il Permesso G; il datore di lavoro svizzero lo presenta all'ufficio della migrazione di quel canton dopo la firma del contratto. Regole sulla zona di frontiera e tempi di lavorazione variano per paese confinante e canton — verifica i dettagli con l'ufficio della migrazione del canton Basilea o con HR durante il colloquio.
Come mi candido a questa posizione presso Roche?
Usa il pulsante "Candidati ora" in questa pagina — rimanda direttamente all'annuncio originale di Roche su roche.wd3.myworkdayjobs.com, quindi la tua candidatura arriva direttamente nel sistema di gestione candidature del datore di lavoro. Frontaliere Ticino non raccoglie né inoltra candidature in proprio.
