Regulatory Operations - Group Lead/Senior Group Director

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. Join Roche, where every voice matters.

The Position

The Opportunity

The Regulatory Operations - Group Lead serves as the Line Manager of the PDR China Regulatory Operations (RO) team and dotted line to global Regulatory Data & Content Chapter Lead. The role is tasked with leading end-to-end data interpretation, generation and execution of data & content strategy, insight generation to guide submission strategy, quality & compliance, and leadership of submission planning and management for clinical projects in the Roche China portfolio.

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; Lead applying scientific/medical writing and data interpretation to manage the regulatory content life-cycle from early planning to market maintenance..

• Submissions Management & Digital Innovation:

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.

• Partnering with PDR TAs and PTR & Capacity Planning:

Act as the primary operational partner to the 5 Therapeutic Area (TA) and PTR Regulatory Leads. 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:

-Coaching & Support: Dedicate substantial effort (~30% of working time) as a VACC leader to empower individuals, foster trusted relationships, and coach direct reports in personal/ professional growth and problem-solving.

-Culture & Environment: Foster an inclusive, empowered, and agile environment; build a team culture that encourages continuous learning, calculated risk-taking, and active knowledge sharing.

-Performance & Development: Continuously assess performance based on impact rather than activity; actively develop internal talent and pipeline.

-Administration: Oversee talent acquisition, resource prioritization, and workforce planning administration.

Who you are

The ideal person for this role will have the following experience, skills, and attributes:

• Proven track record and in-depth expertise in regulatory operations, drug development, regulatory data & content strategy, and submission management (eCTD/eSub, RIM architecture) in China and global environments.

• Demonstrated passion for driving technology evolution, next-gen automation, AI tools, and process optimization within regulatory affairs.

• Strong VACC (Visionary, Architect, Coach, Catalyst) leadership style with a growth mindset, curiosity, and a proven ability to direct teams during complex submissions or critical time-sensitive scenarios.

• Strong people management skills, with a focus on talent development, coaching, and dedicating time to building high-performing, empowered teams.

• Comprehensive experience in Quality & Compliance (QMS, GCP, GVP, audit/inspection readiness) and risk mitigation.

• Demonstrated ability to establish trusted relationships with senior internal and external stakeholders, including Health Authorities, global regulatory counterparts, and industry networks.

• University or higher degree in pharmaceutical, life sciences, or related disciplines with 10+ years of relevant experience in R&D-based pharmaceutical companies.

Application Instructions

Qualified candidates are invited to submit their resume outlining their relevant experience and why they are a perfect fit for this role. This job description outlines the responsibilities and qualifications for a senior management role that requires a balance of strategic regulatory execution, operational compliance, and proactive leadership within a complex, matrixed organization.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.