Global Regulatory Affairs Business Operations Leader

2 weeks ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time
Job Summary

Gilead Sciences, Inc. is seeking a highly skilled and experienced professional to lead our Regulatory Business Process Management team. As the Head of Regulatory Business Process Management, you will be responsible for developing and implementing global regulatory affairs infrastructure, compliance, process, and capability development. This role will play a critical leadership role in driving excellence in our day-to-day operations, enabling talented people to do their best work.

Key Responsibilities

• Lead the Regulatory Business Process Management team, incorporating the wider Centralized Process Team (CPT) and Regulatory Learning & Development dedicated staff, with responsibilities for identification, development, refinement, and continuous improvement of processes, standards, practices, efficiencies, and capabilities within the Regulatory Affairs Department and wider company.
• Lead the incubation period for new process and departmental initiatives and appropriate RA capabilities.
• Hire, develop, and retain diverse top talent on the team. Set clear and elevating goals for the team and individual direct reports. Coach team on their performance, development, and career interests.
• Make significant contributions to our abilities to hire, develop, and retain diverse talent with impact in and outside own team.
• Accountable for the successful oversight and completion of a broad spectrum of regulatory operational activities.
• Develop collaborations with key Regulatory and cross-functional stakeholders to analyze and identify key business drivers and work with the Senior Leadership team to prioritize these, before driving implementation of agreed improved initiatives.
• Interface with key internal business stakeholders and external groups, including CONNECT, GLPS, R&D Quality and Medical Governance, and RSQ Outsourcing.
• Ensure suitable resources and skills are in place to deliver the required continuous improvement culture throughout Global Regulatory Affairs. Work with Regulatory functions to develop suitable training programs.
• Proactively identify regulatory or related risks/issues and external leadership, governance ensures timely development of mitigation and decision-making forums, including contingency plans.
• Own and manage budget and resource plans for assigned area and projections and tracking across the Global Regulatory Organization in close collaboration with the Head of Business Operations for Regulatory Affairs.
• Ensure team's work complies with established practices, policies, and processes, and any regulatory or other requirements.
• Ensure suitable processes are in place for Global Regulatory Affairs to function efficiently and in compliance and tracking through to completion.
• Collaborate with the Head of Vendor Governance and Management Regulatory Affairs and coordinates provision of performance metrics on vendor use across the Global Regulatory Organization.

Requirements

• Extensive experience leading global teams and projects in regulatory or related policies, strategies, programs, projects, and other activities.
• Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products.
• Experience working as a Global or Regional Regulatory Lead within one or more Gilead therapeutic areas and at varying stages of drug development is strongly preferred.
• Multiple years' line management (direct reports) experience. May have experience managing other people leaders (with indirect reports).
• Proven abilities to independently lead a diverse global team.
• Proven track record of achieving or exceeding large-scale, complex short- and long-range strategies in life sciences.
• Has a strong and established external network of regulatory, other governmental and industry leaders and decision-makers.
• Extensive experience interacting with and presenting to executives and managing large-scale project budgets and other resources.
• Experience and proven effectiveness working with regulatory authorities.

Knowledge & Other Requirements

• Expert knowledge of the drug development process, global and regional regulatory requirements, and other business functions, as evidenced by proven track record of leading organizations and teams to achieve short- and long-range strategies, plans, and objectives.
• Organizational design and transformation leadership experience.
• May lead and individually contribute to the maturity of the RA Capability Development Framework.
• Proven ability to influence up, down, and across the organization and externally in a collaborative manner.
• Strong executive presence with demonstrated influence through leadership both on program teams and organizational initiatives.
• Exceptional interpersonal skills and understanding of team dynamics.
• Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution. Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans, and strategic objectives.
• Strong negotiation and conflict resolution skills. Advanced coaching capabilities to mentor/develop staff.
• When needed, ability to travel.

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