Regulatory Affairs Systems and Data Leader

5 days ago


Cambridge, Cambridgeshire, United Kingdom Mundipharma International Full time
Job Description

This is a permanent position based in Cambridge with the possibility of hybrid or flexible work arrangements.

We are looking for an experienced manager to oversee our regulatory systems and data within the Mundipharma International organization.

The ideal candidate will have a proven track record in regulatory operations, data management, and system governance. They should possess excellent knowledge of regulatory processes, dependencies, and risks.

The salary for this role is estimated to be around £80,000 - £100,000 per annum, depending on experience.

Responsibilities

  • Develop and implement strategies for regulatory systems and data management.
  • Oversight of the regulatory information management system (RIM) and external data squad team.
  • Management of submission management and publishing teams.
  • Evaluate new technologies for future enhancements and improvements.
  • Ensure compliance with regulatory guidelines and requirements.

Requirements

  • Proven experience in regulatory operations, data, and system management.
  • Excellent understanding of regulatory processes, dependencies, and risks.

Benefits

  • Flexible benefits allowance.

About Us

Mundipharma International is a company dedicated to bringing innovative treatments to patients in various areas, including Pain Management, Infectious Disease, and Consumer Healthcare.



  • Cambridge, Cambridgeshire, United Kingdom Mundipharma Full time

    Role SummaryThe Regulatory Affairs Systems and Data Manager will be responsible for the strategy and management of all systems and data within the regulatory affairs function. This includes the oversight of the regulatory information management system (RIM) and the external regulatory systems support team.Key ResponsibilitiesManage the RIM system, including...


  • Cambridge, Cambridgeshire, United Kingdom Mundipharma International Full time

    Job SummaryMundipharma International is seeking a highly skilled Regulatory Affairs Systems and Data Manager to join our team. As a key member of our regulatory affairs function, you will be responsible for the strategy and management of all systems and data within the regulatory affairs function.Key ResponsibilitiesDevelop and implement the overall strategy...


  • Cambridge, Cambridgeshire, United Kingdom Mundipharma International Full time

    Job Title: Regulatory Affairs Systems and Data ManagerJob Summary:Mundipharma International seeks a highly skilled Regulatory Affairs Systems and Data Manager to join our team. The successful candidate will be responsible for the strategy and management of all systems and data within the regulatory affairs function.Key Responsibilities:Develop and implement...


  • 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 US TECH SOLUTIONS LIMITED Full time

    US TECH SOLUTIONS LIMITED seeks a highly skilled Regulatory Affairs Data Entry Specialist to join their team in Cambridge, UK. As a key member of the CMC regulatory operations team, the successful candidate will be responsible for performing data entry using the Client RIM System to support key stakeholders.Key ResponsibilitiesEnter relevant information to...


  • 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

    About the RoleWe are seeking an experienced Regulatory Affairs professional to join our global team at Gilead Sciences International, Ltd.Key ResponsibilitiesDevelop and implement regulatory strategies for assigned products or projects.Collaborate with cross-functional teams to shape dossier content for global rollout and life cycle management.Oversee the...


  • Cambridge, Cambridgeshire, United Kingdom Mundipharma International Full time

    Job SummaryWe are seeking a skilled manager to lead our regulatory affairs systems and data management function.This is a permanent role based in Cambridge with potential for hybrid or flexible work arrangements.The successful candidate will have significant experience in regulatory operations, data management, and system governance, as well as excellent...


  • Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full time

    About the JobIn a continuous effort to grow and expand our services, ProductLife Group is looking for a Regulatory Affairs Specialist to join our team in the United Kingdom.This position plays a vital role in developing our local UK Regulatory Affairs presence, overseeing new regulatory activities related to the UK for multiple clients. You will work closely...


  • Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full time

    About the RoleProductLife Group is seeking a highly skilled Regulatory Affairs Specialist to join our team in the United Kingdom. As a key member of our Regulatory Affairs team, you will be responsible for developing and implementing regulatory strategies to support our clients in the UK and EU markets.Key ResponsibilitiesProvide guidance and support to...


  • 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...


  • Cambridge, Cambridgeshire, United Kingdom VCLS Full time

    Regulatory Affairs SpecialistWe are expanding our Clinical Trial Submissions (CTS) group and are 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. You'll have the opportunity to work under a generous,...


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

    About the Role:Gilead Sciences International, Ltd. seeks an experienced Regulatory Affairs Director to lead our biologics efforts in a dynamic global team environment.Job Summary:This key leadership position requires a seasoned professional with expertise in CMC regulatory affairs and strong leadership presence to oversee EU Regulatory submissions and drive...


  • 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 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 Bicycle Therapeutics Full time

    Job OverviewWe are seeking a highly skilled Senior Associate, Regulatory Affairs to join our team at Bicycle Therapeutics. As a key member of our regulatory affairs department, you will be responsible for the development, execution, and tracking of global regulatory submissions for assigned programs or projects.


  • 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 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...


  • 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 Newton Colmore Consulting Full time

    Job Description: Quality Assurance and Regulatory Affairs ExpertCompany Overview:Newton Colmore Consulting is a leading consulting firm in the medical devices industry, providing expert advice on regulatory affairs and quality assurance. We are committed to delivering high-quality services that meet the needs of our clients, and we are seeking a talented...