Director, Regulatory Affairs Labeling Compliance
6 days ago
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
FUNCTION: Regulatory Affairs (RA) Labeling
POSITION OVERVIEW:
Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. Product information and labeling documentation contains the most accurate product use, benefits, dosage/application, and safety information, such as side effects and other safety guidelines for patients and healthcare providers. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate delivery of product information and labeling updates, including other Development teams, Legal, Commercial, and external regulatory agencies.
You will play a key role in advancing compliance excellence within the Global Labeling team at Gilead. This position will focus on optimizing tools, systems, and processes to support proactive compliance management. Collaborating closely with Global Labeling, Regulatory, Patient Safety and Manufacturing teams, you will ensure the seamless execution of labeling changes and provide critical support during global audits and inspections.
As an individual contributor, you will work cross-functionally across Gilead and with strategic partners to enhance the efficiency, accuracy, and compliance of Company Core Data Sheets (CCDS) alignment, distribution, as well as the tracking of labeling changes.
This newly created role within the Innovation, Content, and Execution (ICX) team carries significant responsibility for shaping and evolving global regulatory and labeling policies, tools, procedures, and capabilities—driving continuous improvement and innovation across Gilead.
EXAMPLE RESPONSIBILITIES:
Operational Excellence:
Oversee the development and management of implementation of global labeling and review processes, metrics, and systems.
Provide oversight of country labeling deviations from the CCDS through reporting and collaboration with Global Labeling Leads.
Support the design, implementation, and continuous improvement of standardized processes, Standard Operating Procedures (SOPs), and work instructions related to labeling compliance and tracking.
Work to optimize the workflow for the distribution and tracking of CCDS, ensuring seamless communication and execution across all departments.
Provide guidance to liaison and affiliate teams on the implementation of labeling changes, ensuring consistency and quality at every stage of the product lifecycle.
Develop key performance indicators (KPIs) and identify opportunities for further operational improvements, driving a culture of continuous improvement within labeling.
Innovation in Tools and Technologies:
Support key initiatives aimed at identifying, evaluating, and implementing new tools, technologies, and systems for the distribution of global labeling changes.
Support the integration of advanced tools for efficient management of CCDS distribution, regulatory tracking, and labeling change implementations across multiple affiliates.
Inform Gilead on emerging technologies within regulatory labeling to ensure the use of state-of-the-art tools, which will reduce lead time and improve the accuracy of labeling updates globally.
Proactive Compliance Management:
Support the development and compliance to labeling processes in place to meet global regulatory requirements and internal compliance standards.
Proactively track and report on safety-related changes to labeling, ensuring that the most current and accurate information is consistently reflected in CCDS documents.
Monitor and maintain audit-ready documentation for labeling activities, ensuring that all changes are traceable and fully compliant with local and international regulations.
Collaborate with stakeholders to ensure compliance with regulatory bodies and inspections, providing necessary data when required.
Support the LAT and Pharmacovigilance team during regulatory inspections and audits, ensuring the accuracy and availability of relevant labeling documentation.
Impactful Execution:
Collaborate with Labeling, Liaisons, Affiliates and PDM to ensure all packaging and labeling changes are executed within required timelines.
Manage the tracking and coordination of labeling activities, including artwork approvals, change management, and regulatory assessments.
Ensure that all internal stakeholders, including regulatory affairs, legal, and marketing teams, are aligned and aware of any updates to labeling and packaging requirements.
Prioritize tasks effectively, ensuring that labeling changes are implemented on schedule to meet regulatory deadlines and support successful product launches.
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.
Education & Experience
Extensive experience in prescription drug labeling. Extensive experience leading development of end to end labeling process regulatory labeling or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional leaders and teams for multiple medicinal products.
Significant experience in global management of drug labeling, including core labeling and regional labeling across U.S., EU, GB, Australia, Canada, Japan, Switzerland, and other markets.
Experience leading global teams and projects in regulatory or related strategies, programs, projects, and other activities.
-
United Kingdom Bloom Regulatory Full time €28,000We’re looking for a dedicated and proactive individual who is passionate about the beauty industry and the vital role of regulatory expertise. About Us Bloom Regulatory is a regulatory consultancy specialising in cosmetic product compliance and regulatory interpretation and advice. Founded in 2019, we are a London-based consultancy (although all team...
-
FMCG Labeling Compliance Specialist
3 weeks ago
Uxbridge, United Kingdom Vertical Advantage Full timeWe are looking for a Labeling Compliance Specialist to join a leading drinks business in London. This role focuses on label development, compliance management, and regulatory affairs within the FMCG sector.Responsibilities:You will oversee label compliance for EU markets, working closely with marketing and design teams to develop accurate product labels....
-
Regulatory Affairs Specialist
2 weeks ago
Uxbridge, United Kingdom Advocate Group Full timeThis is your chance to elevate your career with one of the most iconic, highest-performing energy drink and lifestyle brands in the industryAdvocate Group is working in close partnership with one of the world's fastest-growing FMCG brands, in the search for a talented individual to join their ever-growing NPD & Operations function. The Regulatory Affairs...
-
Uxbridge, England, United Kingdom Norgine Full timeABOUT THE JOBWant a 3D Career? Join Norgine.At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.Bring everything about yourself that you're proud of,...
-
Associate Director, Regulatory Affairs CMC
3 days ago
Uxbridge, England, United Kingdom TN United Kingdom Full timeSocial network you want to login/join with:Associate Director, Regulatory Affairs CMC, UxbridgeClient:Gilead Sciences International, Ltd.Location:Uxbridge, United KingdomJob Category:OtherEU work permit required:YesJob Reference:3cda3abe245eJob Views:20Posted:16.03.2025Expiry Date:30.04.2025Job Description:DescriptionWe are looking for an experienced...
-
Fully Remote
4 weeks ago
United Kingdom VRS Regulatory Full timeAbout the Role - An excellent opportunity for a biocide regulatory specialist who is looking for a career step into managing a small team. You will provide strategic advice, expertise, and manage the workload and development of more junior biocide colleagues. This role will be a combination of hands-on technical registration work, project management and...
-
Admin Advisor
4 weeks ago
United Kingdom Bloom Regulatory Full time €28,000We’re looking for a dedicated and proactive individual who is passionate about the beauty industry and the vital role of regulatory expertise. Bloom Regulatory is a regulatory consultancy specialising in cosmetic product compliance and regulatory interpretation and advice. Founded in 2019, we are a London-based consultancy (although all team members work...
-
Associate Director Global Regulatory Affairs
3 weeks ago
Uxbridge, United Kingdom Griffinfire Full timeWant a 3D Career? Join Norgine.At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.Bring everything about yourself that you're proud of, whether that's...
-
Associate Director Global Regulatory Affairs
3 weeks ago
Uxbridge, United Kingdom Internetwork Expert Full timeWant a 3D Career? Join Norgine.Scroll down for a complete overview of what this job will require Are you the right candidate for this opportunityAt Norgine, our colleaguesDarethemselves to be different and try new things,Driveto achieve their goals and beyond, andDevelopthemselves and their community.We call it the3D careerat Norgine and it offers you a...
-
Associate Director Global Regulatory Affairs
3 weeks ago
Uxbridge, United Kingdom Griffinfire Full timeWant a 3D Career? Join Norgine.Scroll down to find an indepth overview of this job, and what is expected of candidates Make an application by clicking on the Apply button.At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.We call it the 3D career...
-
Associate Director Global Regulatory Affairs
3 weeks ago
Uxbridge, United Kingdom Internetwork Expert Full timeWant a 3D Career? Join Norgine.At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.Bring everything about yourself that you're proud of, whether that's...
-
Head of Regulatory Affairs
3 days ago
greater manchester, england, United Kingdom JR United Kingdom Full timeSocial network you want to login/join with:Head of Regulatory Affairs, Greater ManchesterClient:Blackfield AssociatesLocation:Greater ManchesterJob Category:OtherEU work permit required:YesJob Views:1Posted:30.03.2025Expiry Date:14.05.2025Job Description:Blackfield is supporting a pharmaceutical distribution and parallel import group of companies, based in...
-
Uxbridge, England, United Kingdom TN United Kingdom Full timeSocial network you want to login/join with:Client:Gilead SciencesLocation:Uxbridge, United KingdomJob Category:OtherEU work permit required:YesJob Reference:998c7b603eeeJob Views:101Posted:14.03.2025Expiry Date:28.04.2025Job Description:Job DescriptionAt Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases...
-
Uxbridge, England, United Kingdom Gilead Sciences, Inc. Full timeRegulatory Affairs Manager – Oncology Cell TherapyJob DescriptionKite, a Gilead company, is grounded by one common goal – curing cancer. We are at the forefront of immunotherapy and engineered T cell therapy. Our personalized approach is what sets us apart. Unlike traditional pharmaceutical manufacturing, our therapies are not created on an assembly...
-
Biocide Regulatory Lead
4 weeks ago
United Kingdom VRS Regulatory Full timeAbout the Role - An excellent opportunity for a biocide regulatory specialist who is looking for a career step into managing a small team. You will become this company’s go-to biocide person. You will provide strategic advice, expertise, and manage the workload and development of more junior biocide colleagues. This role will be a combination of hands-on...
-
Associate Director Global Regulatory Affairs
3 weeks ago
Uxbridge, United Kingdom Norgine Full timeWant a 3D Career? Join Norgine.The following information aims to provide potential candidates with a better understanding of the requirements for this role.At Norgine, our colleaguesDarethemselves to be different and try new things,Driveto achieve their goals and beyond, andDevelopthemselves and their community.We call it the3D careerat Norgine and it offers...
-
Head Of Regulatory Affairs
4 days ago
Manchester, England, United Kingdom Smart4Sciences Full timeRole: Head of Regulatory AffairsSalary: up to £65,000Location: ManchesterAn exciting role has come available for an experienced Head of Regulatory Affairs to join a pharmaceutical company in Manchester. The role will be leading and managing the work of Regulatory Officers and ensuring the effective day-to-day running of the department.Responsibilities:Lead...
-
Regulatory Affairs
4 weeks ago
United Kingdom Campden BRI Full timeCampden BRI support our members with global Regulatory Support, across the UK, EU and internationally, we are looking for a 12 month fixed term contract to support us. The structure of food and drink legislation varies significantly around the world – Our experienced team of regulatory experts can help you ensure that your products are compliant with...
-
Uxbridge, England, United Kingdom Gilead Sciences, Inc. Full timeRegulatory Affairs Manager – Oncology Cell TherapyUnited Kingdom - Uxbridge, United Kingdom - CambridgeJob DescriptionKite, a Gilead company, is grounded by one common goal – curing cancer. We are at the forefront of immunotherapy and engineered T cell therapy. Our personalized approach is what sets us apart. Unlike traditional pharmaceutical...
-
Regulatory Affairs Lead
4 days ago
north east, england, United Kingdom Vertex Resourcing Full timeRegulatory Affairs Lead - Challenger BrandDriving Compliance Strategy - Rapid Growth CPG Co.Job DescriptionIf you're an aspiring reg affairs leader with a passion for driving growth via delivery of expert compliance strategy, this is one for youReporting directly to the Head of Marketing / Innovation, this newly created role will see you take the lead in all...
