Regulatory Operations - Group Lead/Senior Group Director — Roche
- Location
- Basel
- Contract
- full-time
- Posted
- Yesterday
Role overview
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;
Main responsibilities
- 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:
Application process
- 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.
Additional details
- 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 and original content
- 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 about this listing
What salary does Roche offer for this role?
Roche lists CHF 123'000 - 165'500 gross per year for this position in Basel. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Roche offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Roche during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Basel?
EU/EFTA residents living in the border zone of the country adjoining Canton Basel can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Basel's cantonal migration office or with HR during the application.
How do I apply for this position at Roche?
Use the "Apply now" button on this page — it links directly to Roche's original listing at roche.wd3.myworkdayjobs.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
