Current jobs related to Head of Regulatory Affairs Operations - Cambridge, Cambridgeshire - Gilead Sciences, Inc.

  • Head of Regulatory Affairs Operations

    4 weeks ago

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

    Job Title: Head of Business Operational Excellence M/FDescriptionPOSITION OVERVIEW:Gilead Sciences, Inc. is seeking a highly skilled and experienced professional to lead our Business Operational Excellence function. As a key member of our Global Regulatory Affairs team, you will be responsible for developing and implementing processes and frameworks to drive...

  • Head of Regulatory Affairs Operations

    1 month ago

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

    Job Title: Head of Business Operational Excellence M/FDescriptionPOSITION OVERVIEW:Gilead Sciences, Inc. is seeking a highly skilled and experienced professional to lead our Business Operational Excellence function. As a key member of our Global Regulatory Affairs team, you will be responsible for developing and implementing processes and frameworks to drive...

  • Head of Regulatory Affairs Operations

    4 weeks ago

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

    Job SummaryWe are seeking a highly experienced and skilled professional to lead our Regulatory Affairs Operations team. As the Head of Regulatory Affairs Operations, you will be responsible for developing and implementing global regulatory strategies, managing regulatory processes, and ensuring compliance with regulatory requirements.Key...

  • Global Regulatory Affairs Business Operations Leader

    3 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 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...

  • Global Regulatory Affairs Business Operations Lead

    3 weeks ago

    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...

  • Regulatory Affairs Manager

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Vectura Full time

    Regulatory Affairs ManagerVectura Group is a global leader in developing innovative inhaled therapies and drug-device combination products (DDCPs). We are seeking a skilled and motivated Regulatory Affairs Manager to join our team and help drive the success of our medical device and DDCP regulatory activities.Key Responsibilities:Regulatory Leadership:...

  • Regulatory Affairs Business Operations Leader

    1 week ago

    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...

  • Global Regulatory Affairs Leader

    3 weeks ago

    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...

  • Global Regulatory Affairs Business Operations Lead

    3 weeks ago

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

    Job SummaryGilead 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...

  • Regulatory Affairs Specialist

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom Vectura Group Full time

    Regulatory LeadershipVectura Group, a global leader in inhaled therapies and drug-device combination products, seeks a seasoned Regulatory Affairs Manager to drive the success of our medical device and DDCP regulatory activities.Regulatory Expertise: Lead regulatory activities across Vectura Group, specializing in medical devices and DDCPs, to support...

  • Regulatory Affairs Specialist

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Regulatory Affairs and Quality Assurance AssistantWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Assistant to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices team, you will play a crucial role in ensuring the quality and regulatory compliance of our clients' products.Key...

  • Regulatory Affairs Specialist

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Regulatory Affairs and Quality Assurance AssistantWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Assistant to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices team, you will play a crucial role in ensuring the quality and regulatory compliance of our clients' products.Key...

  • Regulatory Affairs Director

    4 weeks ago

    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...

  • Regulatory Affairs Director

    4 weeks ago

    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...

  • Regulatory Affairs Director

    4 weeks ago

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

    Associate Director, Regulatory AffairsCpl Life Sciences is seeking an experienced Associate Director, Regulatory Affairs to join our team. This is a permanent, full-time opportunity based in Cambridge, UK, with a hybrid/remote work arrangement.About the RoleWe are looking for a highly skilled and motivated individual to lead our regulatory affairs strategy...

  • Regulatory Affairs Director

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    About the RoleMoonLake Immunotherapeutics is seeking an experienced Regulatory Affairs professional to join our team as an Associate Director, Regulatory Affairs. This is an exciting opportunity to contribute to the development and delivery of innovative global regulatory strategies for sonelokimab lead indication(s).Key ResponsibilitiesDevelop and implement...

  • Regulatory Affairs Director

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    About the RoleMoonLake Immunotherapeutics is seeking an experienced Regulatory Affairs professional to join our team as an Associate Director, Regulatory Affairs. This is an exciting opportunity to contribute to the development and delivery of innovative global regulatory strategies for sonelokimab lead indication(s).Key ResponsibilitiesDevelop and implement...

  • Regulatory Affairs Director

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job OverviewMoonLake Immunotherapeutics is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing innovative global regulatory strategies for our lead indication(s).You will work closely with our functional colleagues and project teams to ensure...

  • Regulatory Affairs and Quality Assurance Specialist

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Job Title: Regulatory Affairs and Quality Assurance SpecialistWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a key member of our team, you will be responsible for providing quality assurance and regulatory affairs advice on the creation of new products and the...

  • Regulatory Affairs Director

    1 week ago

    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...

Head of Regulatory Affairs Operations

2 months ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time
Job Title: Head of Business Operational Excellence M/F

Description

POSITION OVERVIEW:

Gilead Sciences, Inc. is seeking a highly skilled and experienced professional to lead our Business Operational Excellence function. As a key member of our Global Regulatory Affairs team, you will be responsible for developing and implementing processes and frameworks to drive excellence in our day-to-day operations.

Responsibilities:

  1. Lead the development and implementation of process improvements and frameworks to drive excellence in Global Regulatory Affairs.
  2. Collaborate with cross-functional teams to identify and prioritize business drivers and develop strategies to address them.
  3. Develop and manage budgets and resource plans to support the Business Operational Excellence function.
  4. Ensure compliance with established practices, policies, and processes, and regulatory requirements.
  5. Lead the incubation period for new process and departmental initiatives and appropriate RA capabilities.
  6. Develop and implement training programs to support the development of the Business Operational Excellence team.
  7. Proactively identify regulatory or related risks/issues and develop mitigation and decision-making forums.
  8. Collaborate with the Head of Vendor Governance and Management Regulatory Affairs to coordinate provision of performance metrics on vendor use.

Requirements:

We are seeking a highly experienced professional with a strong track record of leading global teams and projects in regulatory or related policies, strategies, programs, projects, and other activities. The ideal candidate will have:

  • 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.
  • 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.
  • Has a strong and established external network of regulatory, other governmental and industry leaders and decision-makers.
  • Experience and proven effectiveness working with regulatory authorities.

Equal Employment Opportunity (EEO)

Gilead Sciences, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment that values diversity and promotes equal opportunities for all employees.