Regulatory Operations - Group Lead/Senior Group Directeur — Roche
- Lieu
- Basel
- Contrat
- full-time
- Publié
- Hier
Vue d’ensemble du poste
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;
Responsabilités principales
- 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:
Processus de candidature
- 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.
Détails supplémentaires
- 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.
Notes et contenu original
- 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:
Questions sur cette offre
Quel salaire propose Roche pour ce poste ?
Roche indique CHF 123 000 - 165 500 bruts par an pour ce poste à Basel. Il s'agit du salaire publié dans l'annonce d'origine (ou, si l'employeur ne précise pas de montant, d'une estimation réaliste pour le rôle et le secteur) — le calculateur de ce site le convertit en net réel une fois l'impôt frontalier et les cotisations sociales appliqués.
Est-ce un poste à temps plein, et quel type de contrat propose Roche ?
Cette offre est un poste en temps plein. Le type de contrat affiché ici provient directement de l'annonce originale de l'employeur ; confirmez toujours les horaires exacts, le préavis et la durée d'essai avec Roche pendant le processus de candidature, ces détails pouvant varier même au sein de la même catégorie de contrat.
Ai-je besoin d'un permis de frontalier pour un poste dans le canton de Bâle ?
Les résidents UE/AELE domiciliés dans la zone frontalière du pays voisin du canton de Bâle peuvent demander un permis G ; l'employeur suisse le dépose auprès de l'office cantonal des migrations après signature du contrat. Les règles de zone frontalière et les délais varient selon le pays voisin et le canton — confirmez les détails auprès de l'office des migrations du canton de Bâle ou avec les RH pendant la candidature.
Comment postuler à ce poste chez Roche ?
Utilisez le bouton « Postuler maintenant » sur cette page — il renvoie directement à l'annonce originale de Roche sur roche.wd3.myworkdayjobs.com, votre candidature arrive donc directement dans le système de suivi des candidatures de l'employeur. Frontaliere Ticino ne collecte ni ne transmet lui-même les candidatures.
