Director, Regulatory Affairs Therapeutic Area Business Manager

Regulatory Affairs (Ra) Business Operations Manager

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Position Overview : Regulatory Affairs (RA) Business Operations believe talented people deserve a great place to work and excellence in our day-to-day operations enables talented people to do their best work! Our Mission and Purpose is to reduce complexity, improve performance and to differentiate value. In doing this we unleash and enable our people to be purposeful and impactful!

Reporting into the Head of RA Business Operations, RA Performance Excellence, you will act as the RA Therapeutic Area (TA) Business Manager and will be accountable for continuously improving operational efficiency, efficacy, and focus of the RA Therapeutic Area sub-functional Leadership Teams (LT). You will partner with sub-functional leadership to translate the organization's vision into an actionable annual operating plan and establish and manage the sub-functional leadership team's operational rhythm. You will act as the primary service partner to sub-functional SMEs, translating tools and processes from the Business Operations' Centers of Excellence into practical, usable solutions tailored for the TA's ways of working. You will manage the inventory of strategic projects (for the subfunction) and priorities, ensure resources are aligned to the highest-value work, and provide leadership with a clear view of progress against strategic goals. You will lead relevant communication efforts for the TAs and act as a change agent for the roll out of new processes, tools, systems, and technologies.

You will support the RA Performance Excellence function to identify, lead, and implement ad hoc or special projects that continuously improve or otherwise advance the RA Performance Excellence capabilities.

Responsibilities :

• Act as a bridge to ensure alignment with organizational goals, Hub ways of working, and sub-functional execution. Communicates the sub-function's strategic needs across the Hub to influence capability development and ensures the sub-functions benefit from Hub-led initiatives, encompassing but not limited to :
• Vision and Strategy Development
• Initiative Portfolio Management
• Vendor Management
• Strategic Workforce Planning and Resource Management
• Change, Communications and Engagement
• Performance Management
• Regulatory Inspection and Standards Excellence (RISE) Management
• Business Process Excellence
• TA Leadership Team Operations and Evolution
• Build and support a strong liaison community. This includes facilitating the sub-functional leadership team meetings and cross-functional leadership forums.
• Establish meeting cadence and manage agendas so the TA LTs can make timely, well-informed decisions, allocate resources to the highest value uses, and have effective line of sight into the value delivered by the organization.
• Design and facilitate effective meetings by selecting relevant topics, balancing content review with discussion, and moderating dialogue.
• Drive, monitor and improve the overall effectiveness of the TA LTs by managing the team process and introducing solutions to build team effectiveness as necessary.
• Track and monitor LT decisions and actions; hold LT members accountable to decisions and actions.
• Collaborate with your peers in other functions to share best practices, align, and ensure consistency as appropriate.
• Establish goals and KPIs for the supported sub-functions.
• Identify and mitigate risks for business areas within the supported sub-functions.
• Responsibilities Specific to Liaisons
• Represent liaisons on key committees e.g., Functional Area Initiative Review (FAIR).
• Serve as liaison point of contact for process improvement and document management. Assign or lead liaison input to update and develop new process documents ensuring that processes are clear and appropriately reflect the work within the liaison scope.
• Understands and supports the tactical elements of resource management and vendor engagement, ensuring alignment with budget and priorities.
• Contribute to the talent pipeline refinement for liaisons.
• Serve as liaison point of contact and coordinator for inspection responses and any subsequent CAPAs [interim].
• Support the ongoing evolution and operational management of the Business Management Capability
• Establish mechanisms for continuous feedback and improvement to LT and Business Management processes.
• Adapt and refine approaches to respond to evolving business needs, external conditions, and stakeholder expectations.

Basic Qualifications :

Bachelor's Degree and Twelve Years' Experience OR

Masters' Degree and Ten Years' Experience OR

PhD and Eight Years' Experience

Preferred Qualifications :

People Leader Accountabilities :

The salary range for this position is : $191,250.00 - $247,500.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

Gilead Sciences Inc