Dublin, Leinster, Ireland · Hybrid
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 l…
Skills: Pediatric Regulatory Strategy, Regulatory Affairs, Drug Development, Health Authority Negotiations, Risk Assessment
Foster City, California, United States · Hybrid
$243k–$315k/yr
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 l…
Skills: Commercial Strategy, Oncology Pipeline Management, Target Product Profiles, Clinical Development Plans, Market Research
Foster City, California, United States · Hybrid
$226k–$293k/yr
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 l…
Skills: Biostatistics, Clinical Trial Design, Late-phase Clinical Development, Regulatory Submissions, Statistical Analysis
Changsha, Hunan, China · Remote OK
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 l…
Skills: Relationship Building, Negotiation, Pharmaceutical Sales, Analytical Skills, Cross-functional Collaboration
Foster City, California, United States · Hybrid
$169k–$219k/yr
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 l…
Skills: Statistical Programming, SAS Software, CDISC Standards, SDTM, ADaM
Foster City, California, United States · Hybrid
$147k–$190k/yr
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 l…
Skills: Project Management, Oncology, Medical Affairs, Budget Management, Cross-Functional Collaboration
United States · Remote OK
$133k–$172k/yr
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 l…
Skills: Account Management, Pharmaceutical Sales, Clinical Communication, Territory Business Planning, Cross-functional Collaboration
Foster City, California, United States · Hybrid
$146k–$219k/yr
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 l…
Skills: Statistical Programming, SAS Software, CDISC Standards, SDTM, ADaM
La Verne, California, United States · On-site
$56k–$72k/yr
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 l…
Skills: cGMP, SOP Compliance, Packaging Equipment Operation, ERP, MES
Raleigh, North Carolina, United States · Hybrid
$157k–$204k/yr
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 l…
Skills: Process Design, Continuous Improvement, Project Management, Stakeholder Management, Lean
Pudong, Shanghai, China · On-site
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 l…
Skills: Pharmaceutical Marketing, Project Management, Data Analysis, Cross-functional Collaboration, Stakeholder Management
Riyadh, Riyadh Region, Saudi Arabia · Hybrid
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 l…
Skills: Scientific Exchange, Stakeholder Engagement, Clinical Data Translation, Medical Strategy Development, KOL Mapping
Munich, Bavaria, Germany · Hybrid
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 l…
Skills: Customer Engagement Strategy, Omnichannel Approach, Targeting and Segmentation, Resource Allocation, Performance Management
Foster City, California, United States · Hybrid
$243k–$315k/yr
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 l…
Skills: ERP Solution Delivery, SAP S/4HANA, Finance Business Process, Commercial Operations, Record-to-Report
Cambridge, England, United Kingdom · Hybrid
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 l…
Skills: Resource Management, Strategic Workforce Planning, Regulatory Affairs, Data Analytics, Planisware
Tokyo, Japan · Hybrid
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 l…
Skills: Veeva CRM, PromoMats, Salesforce Marketing Cloud, Marketing Automation, Tableau
Foster City, California, United States · Hybrid
$182k–$236k/yr
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 l…
Skills: Strategic Sourcing, Supplier Relationship Management, Contract Negotiation, Clinical Supply Chain, Risk Intelligence
La Verne, California, United States · On-site
$143k–$185k/yr
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 l…
Skills: Quality Control, People Management, GMP Compliance, Laboratory Operations, Analytical Support
Foster City, California, United States · Hybrid
$158k–$204k/yr
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 l…
Skills: Data Science, Machine Learning, SQL, Tableau, Power BI
Edmonton, Alberta, Canada · On-site
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 l…
Skills: Laboratory Operations, People Leadership, Stakeholder Management, Equipment Lifecycle Management, Budget Tracking
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The Director will lead the global pediatric regulatory strategy for assigned products across Virology, Oncology, and Inflammation therapeutic areas. This includes managing regulatory filings, overseeing pediatric commitments, and representing the company in negotiations with health authorities.
Candidates should possess an advanced degree (PharmD/PhD/MS/MBA) or a bachelor's degree with significant experience in pediatric drug development and regulatory procedures. Strong knowledge of US and EU regulatory requirements and proven leadership in managing complex regulatory strategies are required.
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.
Job Description
Global Therapeutic Area (TA) Regulatory Liaisons is a core function within Gilead's Global Regulatory Affairs (GRA) organisation and serves as a critical strategic partner across drug discovery, development, and commercial teams. Global TA Regulatory Liaisons develop regulatory strategic options and work closely with cross-functional leaders and regulatory authorities to determine appropriate pathways to obtain and maintain licensure and optimal formulary listings. These strategies are essential to securing and maintaining licensure for Gilead's medicinal products, proprietary methodologies, and technologies by managing registrations, regulatory filings, and agency communications and interactions across key markets worldwide.
Gilead's Pediatric Center of Excellence is a global hub based in Dublin, Ireland, dedicated to advancing the research and development of treatments for children living with serious diseases, including HIV, viral hepatitis, COVID-19, and cancer.
The Director, Global Regulatory Affairs Liaison – Pediatric Center of Excellence will serve as the Pediatric Regulatory Lead for assigned products and play a key role in developing and executing regulatory strategies, plans, and objectives for pediatric development programmes across the Virology, Oncology, and Inflammation therapeutic areas, aligned with the overall global development strategy for each product. This may include overseeing the development of global pediatric regulatory plans and submissions, monitoring the progress and fulfilment of global pediatric commitments, and guiding and advising colleagues to ensure these activities are completed thoroughly, effectively, and compliantly. The successful candidate will collaborate across multiple functions and partner with global and regional regulatory leaders to explore and advance the use of our medicines as potential treatments for children living with serious diseases.
This role requires the successful candidate to be based in our Dublin office. We will consider suitably qualified candidates from other countries who express an interest, with the understanding that relocation to Dublin would be required and would not be supported by Gilead.
We are all different, yet we all use our unique contributions to serve patients.
Please see below the qualifications and skills we are seeking for this role.
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.
Please apply via the Internal Career Opportunities portal in Workday.
At Gilead, we set – and achieve – bold ambitions to create a healthier world for all people. From our pioneering virology medicines to our growing impact in oncology, we're delivering innovations once thought impossible in medicine. Our focus goes beyond medicines, and we also strive to remedy health inequities and break down barriers to care. We empower our people to tackle these challenges, and we’re all united in our commitment to help millions of people live healthier lives. Social Media Guidelines: https://www.gilead.com/social-media-guidelines
Offices: 333 Lakeside Drive, Foster City, CA 94404, US · 2 Roundwood Avenue, Stockley Park, Uxbridge, UB11 1AF, GB · Culliganlaan 2, Machelen, Flemish Region 1831, BE · 6711 Mississauga Rd, Suite 600, Mississauga, ON L5N 2W3, CA · 650 Cliffside Dr, San Dimas, CA 91773, US
At Gilead, we set – and achieve – bold ambitions to create a healthier world for all people. From our pioneering virology medicines to our growing impact in oncology, we're delivering innovations once thought impossible in medicine. Our focus goes beyond medicines, and we also strive to remedy health inequities and break down barriers to care. We empower our people to tackle these challenges, and we’re all united in our commitment to help millions of people live healthier lives. Social Media Guidelines: https://www.gilead.com/social-media-guidelines
Offices: 333 Lakeside Drive, Foster City, CA 94404, US · 2 Roundwood Avenue, Stockley Park, Uxbridge, UB11 1AF, GB · Culliganlaan 2, Machelen, Flemish Region 1831, BE · 6711 Mississauga Rd, Suite 600, Mississauga, ON L5N 2W3, CA · 650 Cliffside Dr, San Dimas, CA 91773, US
