Regulatory Compliance Specialist

3 weeks ago


Chalfont St Giles, Buckinghamshire, United Kingdom CTI Clinical Trial and Consulting Services Full time
Regulatory Compliance Specialist Job Description

Estimated Salary: $90,000 - $120,000 per year

Job Overview

This role is responsible for ensuring compliance with regulations and guidelines related to clinical trials. Key responsibilities include managing and maintaining Trial Master Files (TMFs), reviewing GEHC study documentation, and supporting internal audits and regulatory inspections.

The ideal candidate will have experience working on Clinical Trials within the pharmaceutical, biotech or healthcare industry and be proficient in electronic clinical trial management systems.

Key Responsibilities:
  • Manage and maintain TMFs in collaboration with vendors.
  • Review GEHC study documentation to ensure compliance with regulations.
  • Support internal audits and regulatory inspections as needed.
Requirements:
  • Prior knowledge of the clinical trial process.
  • Able to work effectively on multiple projects and prioritize tasks.
  • Willing to travel as required.


  • Chalfont St Peter, Buckinghamshire, United Kingdom E-Frontiers Full time

    E-Frontiers is seeking a skilled COINS System Enhancement Specialist to join our IT team in Gerrards Cross, UK. In this role, you will play a crucial part in enhancing our COINS ERP system, ensuring it meets the needs of our customers and supports business growth.The successful candidate will have experience in project support, data migration, and process...


  • Chalfont St Peter, Buckinghamshire, United Kingdom TSL Full time

    Key ResponsibilitiesAs an Enterprise Systems Administrator, your primary responsibilities will include:Daily system health checks and monitoring to ensure optimal performance.Maintaining accurate documentation of system configurations and customisations.You will also be required to generate reports related to system usage, access control, and performance, as...


  • St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time

    Aircraft RegulatoryEstimated salary: $120,000 - $180,000 per annum.Job Description:This role involves post-approval changes of Marketing Authorisations and product life cycle management. The ideal candidate will have a strong understanding of GMP, Quality and Regulatory requirements, as well as proficiency in publishing and compilation of eCTD submissions,...


  • St Albans, United Kingdom Compliance Professionals Full time

    THE COMPANY:Our client is successful and rapidly growing financial services firm.THE RESPONSIBILITIES:Lead and manage the Compliance and AML teams, driving a culture of accountability and excellence, acting as the SMF 16 and SMF 17.Ensure compliance with all relevant laws and regulationsLiaise with regulatory bodiesEnsure all regulatory filings and reports...


  • St Albans, United Kingdom AJ FOX COMPLIANCE Full time

    Are you passionate about navigating complex risk and regulatory challenges?Looking for an opportunity where your expertise in risk and compliance will be valued and make a difference?If you're a proactive problem solver with a passion for risk management, we want to hear from you!An innovative, forward-thinking law firm is seeking a Risk & Compliance Manager...


  • St Albans, Hertfordshire, United Kingdom X4 Life Sciences Full time

    Job Title: Regulatory Compliance ExpertWe offer a salary range of £40,000 to £45,000 for this role.X4 Life Sciences is a leading medical device company seeking a regulatory compliance expert to join its quality team. In this role, you will be responsible for ensuring compliance with regulatory requirements.About the Role:Maintain and improve the QMS,...


  • St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time

    Job Title: Regulatory Affairs Specialist Achieva Group Limited is seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management.About the RoleThe successful candidate will be accountable for the management of...


  • St Albans, Hertfordshire, United Kingdom CV Library Full time

    Job Summary:We are seeking a highly skilled Compliance Risk Specialist to join our team at NLB Solutions. As a key member of the financial services business, you will be responsible for providing compliance and risk services to ensure all relevant activities adhere to regulatory requirements.The successful candidate will report directly to the CFO and manage...


  • St Albans, Hertfordshire, United Kingdom Blackfield Associates Full time

    Job DescriptionWe are looking for a highly skilled Head of Regulatory Strategy and Compliance to join our team at Blackfield Associates. As a senior member of our Crop Treatment and Agricultural Chemical company, you will be responsible for leading a team of Product Scientists and establishing a clear regulatory strategy for our portfolio.Your Key...

  • Compliance Lead Emea

    8 months ago


    Chalfont Saint Giles, United Kingdom GE HEALTHCARE Full time

    **Job Description Summary**: GE Healthcare Pharmaceutical diagnostics (“PDx”) is currently recruiting a team-oriented, self-motivated, and enthusiastic Compliance professional with relevant pharma industry experience to manage and support multiple aspects of GE Healthcare PDx EMEA& Intercontinental Compliance Program. This position is preferably based...


  • St Albans, United Kingdom X4 Life Sciences Full time

    Job Title: Regulatory Affairs OfficerSalary: £40,000 - £45,000Location: Hertfordshire, UKJob Type: PermanentA growing Pharmaceutical manufacturer are looking to expand their Regulatory team with the addition of a Regulatory Affairs Specialist. They are looking for an individual that is hard working and self- motivated to assist with all things...


  • St Albans, Hertfordshire, United Kingdom Premier Engineering Full time

    Job Title: Senior Compliance SpecialistCompany Overview: Premier Engineering is a leading provider of engineering manufacturing solutions, and we are currently seeking an experienced Senior Compliance Specialist to join our team. Salary: £42,000 - £55,000 per annum (dependent on experience)About the Role: As a Senior Compliance Specialist, you will be...


  • St Albans, Hertfordshire, United Kingdom Premier Engineering Full time

    Job OverviewPremier Engineering is seeking an experienced Quality and Compliance Specialist to join their team. As a key member of the engineering department, you will be responsible for ensuring the company's products meet the highest standards of quality and compliance.About the RoleThe ideal candidate will have a strong background in engineering and...


  • Chalfont St. Giles, United Kingdom Ultimate Banking Ltd Full time

    Our client is an established and customer focussed mortgage lending and savings specialist, located in South Buckinghamshire. Owing to growth in the business, they have an new Operational Risk Officer opportunity within their Risk team. The purpose of thisrole is to support the Operational Risk Manager in assurance work, supporting the team in ensuring the...


  • St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time

    Job DescriptionThis position is responsible for managing post-approval changes of Marketing Authorisations and product life cycle management.The ideal candidate will be accountable for the management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations, including variations, notifications, labelling updates, renewals,...


  • Bury St Edmunds, United Kingdom Pure Resourcing Solutions Limited Full time

    Outstanding opportunity to join a specialist, medical product, distribution business in a senior role. Reporting directly to the CEO, the Head of Regulatory Affairs will establish robust processes and systems to ensure compliance to relevant operating standards. With the support of a QA team you will lead a cultural change programme to embed best practice...


  • Bury St Edmunds, United Kingdom Pure Resourcing Solutions Full time

    Outstanding opportunity to join a specialist, medical product, distribution business in a senior role. Reporting directly to the CEO, the Head of Regulatory Affairs will establish robust processes and systems to ensure compliance to relevant operating standards. With the support of a QA team you will lead a cultural change programme to embed best practice...


  • Bury St Edmunds, United Kingdom Pure Resourcing Solutions Full time

    Outstanding opportunity to join a specialist, medical product, distribution business in a senior role. Reporting directly to the CEO, the Head of Regulatory Affairs will establish robust processes and systems to ensure compliance to relevant operating standards. With the support of a QA team you will lead a cultural change programme to embed best practice...


  • Bury St. Edmunds, United Kingdom Pure Resourcing Solutions Full time

    Outstanding opportunity to join a specialist, medical product, distribution business in a senior role. Reporting directly to the CEO, the Head of Regulatory Affairs will establish robust processes and systems to ensure compliance to relevant operating standards. With the support of a QA team you will lead a cultural change programme to embed best practice...


  • Bury St Edmunds, United Kingdom Pure Resourcing Solutions Full time

    Outstanding opportunity to join a specialist, medical product, distribution business in a senior role. Reporting directly to the CEO, the Head of Regulatory Affairs will establish robust processes and systems to ensure compliance to relevant operating standards. With the support of a QA team you will lead a cultural change programme to embed best practice...


  • St Albans, Hertfordshire, United Kingdom Outsourced Professional Administration Ltd Full time

    Job OverviewThe successful candidate will be responsible for providing a Compliance and Risk service to both companies, ensuring all relevant activities adhere to regulatory requirements. This role requires a strong understanding of compliance regulations and risk management principles.Key ResponsibilitiesSupport the Head of Compliance in ensuring procedures...


  • Bury St Edmunds, United Kingdom Pure Resourcing Solutions Limited Full time

    Outstanding opportunity to join a specialist, medical product, distribution business in a senior role. Reporting directly to the CEO, the Head of Regulatory Affairs will establish robust processes and systems to ensure compliance to relevant operating standards. With the support of a QA team you will lead a cultural change programme to embed best practice...