Global Regulatory Affairs Business Operations Lead

4 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 Affairs Business Operations team. As the Global Regulatory Affairs Business Operations Lead, you will be responsible for developing and implementing global regulatory affairs infrastructure, compliance, process, and capability development.

Key Responsibilities

  • Lead the Regulatory Business Process Management and Excellence Team, incorporating the wider Centralized Process Team (CPT) and Regulatory Learning & Development dedicated staff.
  • Develop and implement global regulatory affairs infrastructure, compliance, process, and capability development.
  • Collaborate with key Regulatory and cross-functional stakeholders to analyse and identify key business drivers and work with the Senior Leadership team to prioritise these.
  • 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.

Requirements

  • Extensive experience leading global teams and projects in regulatory or related policies, strategies, programs, projects, and other activities.
  • 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.
  • 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.

About Gilead Sciences, Inc.

Gilead Sciences, Inc. is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. We are committed to advancing the science of medicine and improving the lives of people around the world.



  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Job Description:Gilead Sciences, Inc. is seeking a highly skilled and experienced professional to lead our Regulatory Affairs Business Operations team. As the Global Regulatory Affairs Business Operations Lead, you will be responsible for developing and implementing global regulatory affairs infrastructure, compliance, process, and capability development.Key...


  • 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...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Title: Global Regulatory Affairs LeaderJob Summary: Gilead Sciences International, Ltd. is seeking a highly experienced Global Regulatory Affairs Leader to lead our Global Regulatory Affairs Labeling organization.About the Role:Lead the development and implementation of global labeling strategies to ensure compliance with regulatory requirements.Oversee...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Title: Global Regulatory Affairs Labeling DirectorJob Summary:Gilead Sciences International, Ltd. is seeking a highly experienced Global Regulatory Affairs Labeling Director to lead our Global Regulatory Affairs Labeling organization. The successful candidate will be responsible for developing and implementing global labeling strategies, ensuring...


  • Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job OverviewMoonLake Immunotherapeutics seeks a highly skilled Global Regulatory Affairs Director to lead the development and implementation of innovative global regulatory strategies for sonelokimab lead indication(s).This role will be responsible for regulatory aspects related to product development and approval, aligning with the global business strategy...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Summary:Gilead Sciences International, Ltd. is seeking a highly skilled and experienced Global Regulatory Affairs Liaison to join our team. As a key member of our Global Regulatory Affairs organization, you will play a critical role in ensuring the compliance of our medicinal products with global regulatory requirements.Key Responsibilities:Develop and...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job SummaryGilead Sciences International, Ltd. is seeking a highly skilled Global Regulatory Affairs Liaison to join our team. As a key member of our Global Regulatory Affairs organization, you will play a critical role in ensuring the successful development and approval of our medicinal products.Key ResponsibilitiesDevelop and implement regulatory...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Job Description:Gilead Sciences, Inc. is seeking a highly experienced professional to lead our Global Regulatory Affairs Operations team. As a key member of the organization, you will be responsible for developing and implementing strategic plans to improve regulatory processes, ensure compliance, and drive business excellence.Key Responsibilities:Lead the...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Job Description:We are seeking an experienced Regulatory Affairs Business Operations Leader to join our team at Gilead Sciences, Inc. The successful candidate will be responsible for leading our Regulatory Business Process Management and Excellence Team, incorporating the wider Centralized Process Team (CPT) and Regulatory Learning & Development dedicated...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Key Responsibilities:As a Director, Global Regulatory Affairs, Precision Medicine, you will develop and execute precision medicine regulatory strategies in alignment with the drug global regulatory strategy, collaborating with cross-functional stakeholders across the Gilead therapeutic areas and adhering to the appropriate regulations. You will work closely...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences Full time

    Job DescriptionAt Gilead Sciences, we're dedicated to creating innovative therapies that improve lives worldwide. Our team of experts is passionate about tackling complex diseases, and we're seeking talented individuals to join our mission.Function:Global Therapeutic Area (TA) Regulatory Affairs, VirologyPosition Overview:As a Regional Regulatory Lead,...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time £85,000 - £110,000

    **Regulatory Affairs Director Role Overview**Cpl Life Sciences is seeking a highly experienced Regulatory Affairs Director to lead our global regulatory strategy and drive business growth.As a key member of our team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with global regulations and guidelines.**Key...


  • Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    About the RoleMoonLake Immunotherapeutics is seeking a highly skilled Regulatory Affairs Director to join our dynamic team.This is an exciting opportunity to develop and deliver innovative global regulatory strategies for sonelokimab lead indication(s).As a key member of our team, you will be responsible for regulatory aspects related to product development...


  • Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job Overview At MoonLake Immunotherapeutics, we are seeking an experienced Associate Director of Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will play a critical role in developing and delivering innovative global regulatory strategies for our sonelokimab lead indication(s). Responsibilities * Collaborate with...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences Full time

    Job Overview:At Gilead Sciences, we're dedicated to creating a healthier world for all people. We're seeking a skilled Senior Global Regulatory Affairs Manager to join our team and contribute to the development of life-changing scientific innovations.As a key member of our Global Regulatory Affairs team, you will play a critical role in shaping our...


  • Cambridge, Cambridgeshire, United Kingdom CTI Clinical Trial and Consulting Services Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at CTI Clinical Trial and Consulting Services. As an Associate Director, Regulatory Affairs, you will play a critical role in developing and delivering innovative global regulatory strategies for our sonelokimab lead indication(s).Key Responsibilities:Develop and...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    {"Regulatory Strategy and ComplianceAt Gilead Sciences, Inc., we're committed to developing life-changing scientific innovations that improve lives worldwide. As a key member of our global regulatory affairs team, you'll play a critical role in shaping our regulatory strategy and ensuring compliance with international regulations."}


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Job SummaryWe are seeking an experienced Global Regulatory Affairs Expert to join our team at Gilead Sciences, Inc. This is a key leadership role responsible for defining and implementing regulatory strategies for multiple biopharmaceutical products across various therapeutic areas.About the RoleDevelop and execute global regulatory strategies for assigned...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    We are seeking a highly skilled Business Operations Coordinator to join our team at Gilead Sciences International, Ltd. in Cambridge or Stockley Park.About the RoleThis is an exciting opportunity to work with a global, dynamic, and diverse team within Global Regulatory Affairs. As a Business Operations Coordinator, you will be responsible for ensuring...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time

    Job Title: Associate Director, Regulatory AffairsJob Type: Permanent, full-timeLocations: Cambridge, UK – Hybrid/RemoteRemuneration: £85,000 - £110,000 + benefitsCpl Life Sciences is seeking a highly skilled Regulatory Affairs professional to lead strategy for development programs globally. As an Associate Director, Regulatory Affairs, you will support...