Global Regulatory Affairs Lead

1 day ago


Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time
Associate Director, Global TA Regulatory Liaisons

Gilead Sciences, Inc. is a leading biotechnology company that discovers, develops, and commercializes innovative therapeutics to treat life-threatening diseases.

Salary: $180,000 - $220,000 per year

Job Description:
  • Act as the Regional Regulatory Lead on complex or multiple products, compounds, indications, or projects in the assigned therapeutic area.
  • Define the regulatory strategy, plans, and objectives for assigned products or projects.
  • Lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams.
  • Represent Gilead in negotiations with regulatory authorities.
Required Skills and Qualifications:
  • BA/BS or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry.
  • In-depth knowledge of current global and regional trends in biopharmaceutical regulatory affairs.
  • Demonstrated advanced regulatory and business knowledge and analytical abilities.
Benefits:
  • Competitive salary and benefits package.
  • Opportunities for career growth and professional development.
  • A dynamic and collaborative work environment.


  • Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Strategy Lead to join our team at MoonLake Immunotherapeutics.This is an exceptional opportunity for a seasoned professional with expertise in regulatory affairs and a passion for innovative global strategies to drive drug development.


  • Cambridge, Cambridgeshire, United Kingdom Indo Search Full time

    Job Title: Regulatory Affairs DirectorLocation: Cambridge, UKSalary Range: £150-£200,000 per annumAbout the Role:We are seeking a highly experienced Regulatory Affairs professional to lead our compliance and strategy efforts in the medical device industry.The successful candidate will be responsible for implementing regulatory strategies that align with...


  • 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 Indo Search Full time

    Indo Search is a ground-breaking developer of high-end medical technologies with ambitious plans to scale globally.We are seeking an experienced Regulatory Affairs Director to lead our regulatory team in achieving global compliance for complex Class IIb/III devices.The ideal candidate will have extensive senior-level experience in medical device regulatory...


  • Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job DescriptionMoonLake Immunotherapeutics is seeking a skilled Regulatory Affairs Strategist to develop and deliver innovative global regulatory strategies for sonelokimab lead indication(s). This role will be an integral part of our team, responsible for regulatory aspects related to product development and approval.We are looking for a candidate with a...


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

    At Gilead Sciences, Inc., we're seeking a highly experienced Regulatory Affairs Manager to lead our Global Regulatory team in the development and implementation of regulatory strategies for our Therapeutic Area (TA) portfolio. This role will oversee the preparation and submission of regulatory documents, as well as ensure compliance with global...


  • Cambridge, Cambridgeshire, United Kingdom Vectura Group Full time

    Job SummaryWe are seeking a skilled Regulatory Affairs Specialist to join our team at Vectura Group. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with global regulations and guidelines for medical devices and drug-device combination products.Key Responsibilities:Lead regulatory activities across...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Full time

    About GileadGilead Sciences, Inc. is a global biopharmaceutical company dedicated to developing innovative treatments for life-threatening diseases. We're looking for talented individuals to join our team as Regulatory Affairs Manager.Job DescriptionThis role will act as the Regional Regulatory Lead on complex or multiple products, compounds, indications or...


  • Cambridge, Cambridgeshire, United Kingdom Indo Search Full time

    As a member of our team, you will have the opportunity to work on groundbreaking medical technologies and make a lasting impact. We are seeking a talented Global Regulatory Lead to drive regulatory excellence and compliance for complex Class IIb/III devices.The ideal candidate will have substantial experience in regulatory affairs within MedTech, combining...


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

    Job OverviewWe are seeking a highly experienced Senior Director to lead our Regulatory Affairs team at Cpl Life Sciences. This role will provide strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input.Key Responsibilities:Lead client projects, providing expert regulatory guidance...


  • Cambridge, Cambridgeshire, United Kingdom Dr. Reddy's Laboratories Full time

    Job Title: Regulatory Affairs SpecialistEstimated Salary: $80,000 - $110,000 per annumAbout UsWe are a leading multinational pharmaceutical company based across global locations. Our mission is to accelerate access to affordable and innovative medicines.Job DescriptionThe successful candidate will be responsible for preparation and submission of UK MAA...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job Title: Regulatory Affairs DirectorWe are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at Bicycle Therapeutics. The successful candidate will be responsible for developing and executing global regulatory CMC strategy and submissions for assigned programs or projects.The ideal candidate will have extensive...


  • Cambridge, Cambridgeshire, United Kingdom Tbwa ChiatDay Inc Full time

    Sail Biomedicines is seeking an experienced Global Regulatory Lead to join its team. As a key member of the company's regulatory operations, you will be responsible for developing and executing global registration strategies that enhance the likelihood of regulatory approval.The ideal candidate will have 8+ years of industry experience in regulatory affairs,...


  • Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time

    Regulatory Affairs Director Job OverviewWe are seeking a highly skilled Regulatory Affairs Director to join our team at Lifelancer. As a key member of our organization, you will be responsible for developing and delivering innovative global regulatory strategies for sonelokimab lead indication(s).About the RoleThis is an exciting opportunity to work with a...


  • Cambridge, Cambridgeshire, United Kingdom Tbwa ChiatDay Inc Full time

    We are seeking a highly motivated and experienced Senior Manager of Regulatory Affairs to join our team at Sail Biomedicines. This role will be responsible for developing and executing our regulatory operations and planning, managing, and tracking regulatory submissions.Responsibilities:Develop regional regulatory operations that de-risk and accelerate the...


  • Cambridge, Cambridgeshire, United Kingdom Indo Search Full time

    Regulatory Affairs Director - MedTechWe are seeking a highly experienced Regulatory Affairs Director to join our team in Cambridge, UK. As a key member of our organization, you will be responsible for developing and implementing global regulatory strategies for advanced Class IIb/III medical devices.Key Responsibilities:Develop and implement global...


  • Cambridge, Cambridgeshire, United Kingdom Vertex Ventures HC Full time

    Job Title: Compliance and Regulatory Affairs DirectorAbout Bicycle Therapeutics:We are a clinical-stage biopharmaceutical company dedicated to developing innovative medicines for underserved diseases. Our team is passionate about improving the lives of patients and driving meaningful change in the industry.Job Summary:The Compliance and Regulatory Affairs...


  • Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time

    About LifelancerLifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talented professionals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.Job Title: Global Clinical Program Manager for Biotech Regulatory AffairsWe are seeking a highly skilled Global Clinical Program Manager for our...


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

    OverviewCpl Life Sciences is seeking a Senior Director Regulatory Affairs to join our team. This role offers the opportunity to lead client projects, provide strategic regulatory advice, and ensure compliance with UK, EU, and US health authorities.About the RoleAs Senior Director Regulatory Affairs, you will be responsible for preparing regulatory submission...


  • Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time

    Job DescriptionCompany Overview: Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT.We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains. Our mission is to provide innovative solutions for businesses and professionals in the industry.SalaryThe estimated salary for this position...