Regulatory Affairs Specialist

7 days ago


Leeds, Leeds, United Kingdom MAC Clinical Research Full time
About MAC Clinical Research

MAC Clinical Research is a global Contract Research Organisation (CRO) that provides comprehensive services to the pharmaceutical industry. Our mission is to deliver high-quality research solutions with integrity and honesty, making a significant contribution to human health.

Job Summary

We are seeking a highly skilled Qualified Person to join our team at MAC Clinical Research. As a Qualified Person, you will play a critical role in ensuring the quality and safety of medicinal products.

Key Responsibilities
  • Perform the duties of the Qualified Person as described in Article 51 of Directive 2001/83/EC and the applicable UK Statutory Instrument.
  • Release Investigational Medicinal Products (IMPs) for use in human clinical trials at MAC Clinical Research facilities, ensuring subject safety.
  • Work with and organize the workload of any other contract/trainee QPs employed by MAC.
  • Review and approve Technical Quality Agreements.
  • Act upon product complaints, deviations, and recalls.
  • Ensure the Quality Management System is robust and effectively implemented to support safe IMP manufacture and release.
  • Attend regulatory inspections and GMP Sponsor audits as required.
  • Perform GMP training to staff as required.
  • Undertake Continuing Professional Development as required.
  • Maintain personal training and attend training sessions as required.
  • Comply with MAC's health and safety policy.
  • Comply with MAC's policy on equality and diversity.
  • Maintain professional qualifications required for the role, including continuous personal development.
  • Work according to MAC SOPs, guidelines, and policies.
  • Work according to current data protection standards and practice good information management.
  • Maintain strict confidentiality of patient and business-related data.
Requirements
  • Pharmacy, Biological, or Chemical Science degree.
  • Member of a recognized professional body (Royal Pharmaceutical Society GB, Royal Society of Chemistry, or Institute of Biology).
  • Two or more years' experience of clinical trials within the pharmaceutical industry.
  • Experience in a CRO, Phase 1 Unit, or Hospital pharmacy.
What We Offer
  • Competitive salary in line with pharmaceutical industry standards.
  • Health insurance.
  • Free onsite parking.
  • 25 days annual leave (increasing in increments to 30 days after 6 years' service).
  • Your birthday off work.


  • Leeds, Leeds, United Kingdom Russell Taylor Group Ltd Full time

    Position: Regulatory Affairs Specialist Type: Permanent Compensation: Competitive salary plus bonusAre you enthusiastic about chemical safety and compliance? Do you possess a meticulous attention to detail and a commitment to upholding standards in the chemical sector? Russell Taylor Group Ltd is representing a prominent Chemical organization renowned for...


  • Leeds, Leeds, United Kingdom William Hill PLC Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team at William Hill PLC. As a key member of our organization, you will be responsible for ensuring that our operations meet all relevant regulatory requirements, while also providing strategic advice to stakeholders...


  • Leeds, Leeds, United Kingdom William Hill PLC Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team at William Hill PLC. As a key member of our organization, you will be responsible for ensuring that our operations meet all relevant regulatory requirements, while also providing strategic advice to stakeholders...


  • Leeds, Leeds, United Kingdom BioTalent Full time

    About the RoleWe are seeking a highly skilled and detail-oriented Medical Coordinator to join our team at BioTalent. As a Medical Coordinator, you will play a critical role in managing the Medical, Legal, and Regulatory (MLR) review process for our clients' promotional materials and communications.Key ResponsibilitiesMLR Process ManagementCoordinate and...


  • Leeds, Leeds, United Kingdom BioTalent Full time

    About the RoleWe are seeking a highly skilled and detail-oriented Medical Coordinator to join our team at BioTalent. As a Medical Coordinator, you will play a critical role in managing the Medical, Legal, and Regulatory (MLR) review process for our clients' promotional materials and communications.Key ResponsibilitiesMLR Process ManagementCoordinate and...


  • Leeds, Leeds, United Kingdom Ramboll Group AS Full time

    Senior Regulatory Affairs ConsultantWe are seeking a highly skilled Senior Regulatory Affairs Consultant to join our Health Sciences department at Ramboll Group A/S. As a key member of our team, you will be responsible for providing subject matter expertise in chemical legislation, developing authorisation strategies, and compiling approval/authorisation...


  • Leeds, Leeds, United Kingdom ZipRecruiter Full time

    Job Title: Regulatory Affairs ManagerJob Summary:Russell Taylor Group is recruiting on behalf of our client, a leading provider of passive fire protection systems, for a full-time Compliance Manager. The ideal candidate will have extensive knowledge of the Fire Stopping industry and a strong background in fire safety management.Key Responsibilities:Develop...


  • Leeds, Leeds, United Kingdom VPA London Full time

    Position OverviewVPA London is seeking a dedicated Compliance and Legal Affairs Specialist to enhance our team. This role will be performed in a hybrid work environment.Key Responsibilities:Ensure adherence to all applicable laws, regulations, and internal guidelines.Oversee the organization’s audit processes.Collaborate with senior management to formulate...


  • Leeds, Leeds, United Kingdom Lowell Group Full time

    About the RoleWe are seeking a highly skilled professional to join our team as a Compliance Business Partner. This is an exciting opportunity to work closely with business functions to identify and mitigate regulatory and conduct risk.Key ResponsibilitiesProvide a professional and pragmatic advisory service to business areas on regulatory and compliance...


  • Leeds, Leeds, United Kingdom Lowell Group Full time

    About the RoleWe are seeking a highly skilled professional to join our team as a Compliance Business Partner. This is an exciting opportunity to work closely with business functions to identify and mitigate regulatory and conduct risk.Key ResponsibilitiesProvide a professional and pragmatic advisory service to business areas on regulatory and compliance...


  • Leeds, Leeds, United Kingdom William Hill Full time

    We're seeking a seasoned and experienced Senior Compliance Manager to join our UK team at William Hill. In this role, you will be responsible for ensuring that our operations meet all relevant regulatory requirements, while also providing strategic advice to stakeholders on compliance risks and opportunities.Key Responsibilities:Develop, update, and enforce...


  • Leeds, Leeds, United Kingdom William Hill Full time

    Job OverviewWe are seeking a highly skilled and experienced Senior Compliance Manager to join our team at William Hill. As a key member of our organization, you will play a critical role in ensuring that our operations meet all relevant regulatory requirements, while also providing strategic advice to stakeholders on compliance risks and opportunities.Key...


  • Leeds, Leeds, United Kingdom William Hill Full time

    Job OverviewWe are seeking a highly skilled and experienced Senior Compliance Manager to join our team at William Hill. As a key member of our organization, you will play a critical role in ensuring that our operations meet all relevant regulatory requirements, while also providing strategic advice to stakeholders on compliance risks and opportunities.Key...


  • Leeds, Leeds, United Kingdom Hays Specialist Recruitment Limited Full time

    Job Opportunity: We are seeking an NQ Regulatory Solicitor to join our team at Hays Specialist Recruitment Limited.About the Role: As a Regulatory Solicitor, you will be involved in high-quality work relating to financial services regulatory matters. You will work with a client base that includes banks, private equity firms, and venture capitalists.Key...


  • Leeds, Leeds, United Kingdom SRG Full time

    Job Title: Product Regulatory SpecialistCompany: SRG, a global FMCG product testing companyLocation: West Yorkshire, with hybrid working 2 days a week on siteSalary: Up to £38,000 Depending on ExperienceJob Type: PermanentJob Description:Role Summary:We are seeking a highly skilled Product Regulatory Specialist to join our team at SRG. As a Product...


  • Leeds, Leeds, United Kingdom SRG Full time

    Job Title: Product Regulatory SpecialistCompany: SRG, a global FMCG product testing companyLocation: West Yorkshire, with hybrid working 2 days a week on siteSalary: Up to £38,000 Depending on ExperienceJob Type: PermanentJob Description:Role Summary:We are seeking a highly skilled Product Regulatory Specialist to join our team at SRG. As a Product...


  • Leeds, Leeds, United Kingdom Willow Resourcing Limited Full time

    Job SummaryWe are seeking a highly skilled Regulatory Policy Specialist to join our team at Willow Resourcing Limited. As a key member of our organization, you will play a crucial role in developing and implementing regulatory policies, guidelines, and processes that support our Financial Advisers in delivering exceptional client experiences.Key...


  • Leeds, Leeds, United Kingdom Willow Resourcing Limited Full time

    Job SummaryWe are seeking a highly skilled Regulatory Policy Specialist to join our team at Willow Resourcing Limited. As a key member of our organization, you will play a crucial role in developing and implementing regulatory policies, guidelines, and processes that support our Financial Advisers in delivering exceptional client experiences.Key...


  • Leeds, Leeds, United Kingdom SRG Full time

    A seasoned Product Regulatory Specialist is needed for a leading Consumer Goods company. Experience ensuring and delivering regulatory compliance across a portfolio of Detergents and Home Care products is essential.Key Responsibilities:Efficiently execute and manage regulatory activities to ensure compliance with global standards.Conduct thorough reviews of...


  • Leeds, Leeds, United Kingdom MUFG Pension & Market Services Full time

    Job Summary:The Compliance Associate will join MUFG Pension & Market Services on a 12-month fixed term contract. This role will be based in our city centre office in Leeds, with a hybrid working arrangement requiring regular commutes to the office.About the Role:This Compliance Associate position will report to the Compliance Oversight Manager, who will...