At Gilead, we have been tackling diseases such as HIV, viral hepatitis, COVID‑19, and cancer for more than 35 years, working relentlessly to develop therapies that help improve lives and to ensure global access to these therapies. Our mission requires collaboration, determination, and a relentless drive to make a difference.
Position Overview
The Regulatory Affairs Business Operations – RA Human Capital role reports to the head of RA Human Capital within RA Business Operations, a key group in the broader Regulatory Affairs organization. This position is a strategic partner and advisor to other Regulatory Affairs functions, with a focus on ensuring the worldwide RA organization operates with the highest standards of quality, efficiency, and compliance. The role supports strategic decision‑making and continuous improvement through expertise in operational excellence, best practices, knowledge management, business process and continuous improvement, performance metric setting and reporting, quality and compliance monitoring, vendor and resource management, and training and education for RA colleagues and stakeholders.
Key Responsibilities
Own the data quality, infrastructure, and business practices related to resource management.
Lead special projects and pilots that advance the capabilities of RA Business Operations.
Provide support across Business Operations capabilities as needed (Vendor Management, Business Process Excellence, Inspection Readiness, Change Management, Communications and Engagement).
Make significant contributions to short‑ and long‑range RA strategies, plans, and infrastructure development, and to RSQ and RA‑wide initiatives.
Collaborate within Human Capital (Resource Management and Vendor Management) to drive holistic internal/external resourcing strategies across RA.
Embed resource management concepts and influence the culture and practices within Regulatory Affairs.
Required Qualifications
Expert understanding of the three pillars of resource management: resourcing, resource forecasting, and strategic workforce planning.
Strong analytical skills with the ability to work with complex datasets and provide accurate, timely insights to support headcount utilization and needs at an organizational level.
Proven experience in resource management or a related business operations field within a regulated environment.
Excellent communication, stakeholder engagement, and cross‑functional collaboration skills.
Ability to lead projects, manage teams, and influence organizational culture toward operational excellence.
Benefits and Opportunities
By aligning talent to strategic priorities, you will enable the organization to meet critical submission deadlines, maintain compliance, and build a future‑ready workforce. The role offers opportunities to work with people at all levels, collaborate across disciplines, and support cross‑functional governance and other capabilities.
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Director - Regulatory Affairs Resource, Analytics and Insights Lead
PVH (Tommy Hilfiger/Calvin Klein) · New York, NY, USA ·
- Pay:
- 140.000 - 170.000
- Job type:
- Full Time