Regulatory Affairs Manager

3 days ago


Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time
About the Role

This is an exciting opportunity to join Gilead Sciences, Inc. as a Regulatory Affairs Manager within the Virology Franchise. You will be responsible for developing and executing regulatory strategies for designated products, preparing and maintaining regulatory submissions, and partnering with cross-functional teams.

Responsibilities
  • Manage and lead regulatory strategies for assigned products or projects.
  • Collaborate with local teams to define the regulatory strategy, plans, and objectives for assigned products or projects.
  • Work closely with regulatory, manufacturing, and other parties to ensure compliance with regulatory requirements.
Skills and Qualifications
  • Advanced degree in life sciences or related field.
  • Minimum 5 years of experience in regulatory affairs, preferably in the biopharma industry.
  • Strong knowledge of ICH and regional regulatory requirements.
  • Excellent communication and interpersonal skills.
Location

You can be based at Stockley Park or Cambridge office.



  • 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 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 Gilead Sciences, Inc. Full time

    Job DescriptionWe are seeking an experienced Global Regulatory Affairs Manager to join our team. This role will be responsible for leading the development and implementation of global regulatory strategies for multiple products or projects. The ideal candidate will have a strong background in regulatory affairs, excellent leadership skills, and the ability...


  • Cambridge, Cambridgeshire, United Kingdom Thor Companies Full time

    Regulatory Affairs Expert WantedWe are seeking a Regulatory Affairs Expert to join our team in Cambridge, UK. The successful candidate will have a strong background in pharma/biopharma and be able to work independently.About the Role:The ideal candidate will have at least 10 years' experience in regulatory affairs.Proven ability to manage projects and...


  • Cambridge, Cambridgeshire, United Kingdom Vectura Group plc Full time

    Job SummaryVectura Group plc is seeking a highly skilled Regulatory Affairs Specialist to lead our medical device regulatory activities. This role involves assuming the role of Regulatory Affairs Manager with specialized expertise in medical devices and drug-device combination products (DDCPs). About Vectura Group plcWe are a global leader in developing...


  • 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 VCLS Full time

    We are seeking a highly experienced Regulatory Affairs Expert to join our growing team at VCLS. This role is ideal for someone with 4+ years of experience in regulatory affairs and a strong background in Clinical Trial Submissions.The successful candidate will play a key role in driving forward regulatory processes, ensuring compliance, and contributing to...


  • Cambridge, Cambridgeshire, United Kingdom VCLS Full time

    VCLS is seeking a highly skilled Regulatory Affairs Specialist to drive forward regulatory processes, ensure compliance, and contribute to innovative clinical trials. The ideal candidate will have 4+ years of experience in Regulatory Affairs, with a focus on Clinical Trial Submissions (CTS). They will possess a deep understanding of regional and local...


  • 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 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 Mundipharma Full time

    Job OverviewMundipharma seeks a skilled Data Management and Regulatory Affairs Leader to oversee the strategy and management of all systems and data within the regulatory affairs function.


  • Cambridge, Cambridgeshire, United Kingdom Voisin Consulting SARL Full time

    About VCLSWe are a leading consulting firm offering expert regulatory services to the pharmaceutical and medical device sectors. Our team is dedicated to providing high-quality support to our clients, ensuring compliance with regulatory requirements.This 30-month programme is designed for recent graduates with an interest in medicines and a desire to build a...


  • Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job Title: Regulatory Affairs DirectorMoonLake Immunotherapeutics invites applications for a talented Regulatory Affairs Director to join our team. In this critical role, you will lead the development and execution of global regulatory strategies for sonelokimab lead indication(s).The successful candidate will have extensive experience in regulatory affairs,...


  • 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 VCLS Full time

    Senior Regulatory Affairs SpecialistAt VCLS, we are expanding our Clinical Trial Submissions (CTS) group and seeking an experienced Regulatory Affairs professional to join our team.This role is ideal for someone with 4+ years of experience in regulatory affairs and a strong background in Clinical Trial Submissions.As part of a supportive and collaborative...


  • 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 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 Vertex Ventures HC Full time

    Job Title: Compliance OfficersEstimated Salary: $85,000 - $110,000 per year.Bicycle Therapeutics is a pioneering pharmaceutical company dedicated to developing innovative treatments for complex diseases. As a Senior Associate in Regulatory Affairs, you will play a critical role in shaping the company's regulatory strategy, ensuring compliance with global...


  • Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    At MoonLake Immunotherapeutics, we are seeking a highly skilled Regulatory Affairs Strategist to join our team. This is an exciting opportunity for a motivated individual to develop and implement innovative global regulatory strategies for sonelokimab lead indication(s). The ideal candidate will have a minimum of 7 years of experience in regulatory affairs...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job DescriptionBicycle Therapeutics is a pioneering pharmaceutical company developing innovative medicines for underserved diseases. As Associate Director, Regulatory Affairs CMC, you will play a pivotal role in shaping the regulatory strategy and submissions for our assigned programs or projects.Key ResponsibilitiesDevelop and execute global regulatory CMC...