Description
POSITION OVERVIEW:
Regulatory Affairs 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!
The Business Operational Excellence function works across Gilead Global Regulatory Affairs (GRA) to provide the framework for GRA process development and excellence, controlled documentation development and management and effective learning programs. In addition, leadership of the Incubation Hub will include oversight of all RSQ initiatives involving GRA. The Business Operational Excellence Functional Head will play a leadership role in developing and implementing Global Regulatory Affairs infrastructure, compliance, process, and capability development. The wider Business Operational Excellence team, incorporating Business Process Management and Excellence, the Quality and Compliance Centralized Process Team (CPT) and dedicated staff responsible for Regulatory Learning & Development, will partner closely across Regulatory Affairs and the wider Gilead organization to provide services including, but not limited to GRA business process support, audit readiness support, process improvement support, and compliance monitoring to support a wide variety of regulatory submissions across all therapeutic indications and regions. The team will also identify, lead, and implement ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities (example: Manage Initiatives Portfolio, Manage Capability and Process Frameworks) across the global organization (US, EU, Japan, China, Australia, Canada, Intercontinental and Global Patient Solutions).
RESPONSIBILITIES:
1. Leads the Regulatory Business Process Management and Excellence 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.
2. Leads the incubation period for new process and departmental initiatives and appropriate RA capabilities (example: Manage Initiative Portfolio, Manage Capability and Process Frameworks).
3. Hires, develops, and retains diverse top talent on the team. Sets clear and elevating goals for the team and individual direct reports. Coaches team on their performance, development, and career interests.
4. Makes significant contributions to our abilities to hire, develop and retain diverse talent with impact in and outside own team.
5. Accountable for the successful oversight and completion of a broad spectrum of regulatory operational activities.
6. Develops collaborations with key Regulatory and cross-functional stakeholders, to analyse and identify key business drivers and work with the Senior Leadership team to prioritise these, before driving implementation of agreed improved initiatives.
7. Interfaces with key internal business stakeholders and external groups including CONNECT, GLPS, R&D Quality and Medical Governance, and RSQ Outsourcing
8. Ensures 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.
9. Proactively identifies regulatory or related risks/issues and external leadership, governance ensures timely development of mitigation and decision-making forums, including /or contingency plans.
10. Owns and manages 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.
11. Ensures team’s work complies with established practices, policies, and processes, and any regulatory or other requirements.
12. Ensures suitable processes are in place for Global Regulatory Affairs to function efficiently and in compliance and tracking through to completion.
13. Collaborates 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:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Minimum Education & Experience
14. Extensive experience leading global teams and projects in regulatory or related policies, strategies, programs, projects, and other activities.
15. Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products.
16. 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.
17. Multiple years’ line management (direct reports) experience. May have experience managing other people leaders (with indirect reports).
18. Proven abilities to independently lead a diverse global team.
19. Proven track record of achieving or exceeding large-scale, complex short- and long-range strategies in life sciences.
20. Has a strong and established external network of regulatory, other governmental and industry leaders and decision-makers.
21. Extensive experience interacting with and presenting to executives and managing large-scale project budgets and other resources.
22. Experience and proven effectiveness working with regulatory authorities.
Knowledge & Other Requirements
23. 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.
24. Organizational design and transformation leadership experience.
25. May lead and individually contribute to the maturity of the RA Capability Development Framework
26. Proven ability to influence up, down and across the organization and externally in a collaborative manner.
27. Strong executive presence with demonstrated influence through leadership both on program teams and organizational initiatives.
28. Exceptional interpersonal skills and understanding of team dynamics.
29. 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.
30. Strong negotiation and conflict resolution skills. Advanced coaching capabilities to mentor/develop staff.
31. When needed, ability to travel.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your to apply for this job.