Current jobs related to Regulatory Affairs Specialist - Leeds, Leeds - MAC Clinical Research

  • Regulatory Affairs Specialist

    1 week ago

    Leeds, Leeds, United Kingdom Seven Life Sciences Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Seven Life Sciences. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Review and update technical files for medical...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Senior Regulatory Affairs Manager/ConsultantWe are seeking a seasoned Senior Regulatory Affairs Manager/Consultant to join our team at Lifelancer. As a key member of our regulatory affairs team, you will be responsible for providing expert guidance on regulatory strategies, ensuring compliance with EU guidelines, and managing client relationships.Key...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Senior Regulatory Affairs Manager/ConsultantWe are seeking a seasoned Senior Regulatory Affairs Manager/Consultant to join our team at Lifelancer. As a key member of our regulatory affairs team, you will be responsible for providing expert guidance on regulatory strategies, ensuring compliance with EU guidelines, and managing client relationships.Key...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom NHS England Full time

    Regulatory Affairs Specialist OpportunityAn exciting opportunity has arisen for a skilled Regulatory Affairs Specialist to join the patient safety team within the Transformation Directorate's Digital Clinical Informatics (DCI) team at NHS England.The role will support the quality and regulatory team in implementing and maintaining NHS-England's quality...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom NHS England Full time

    Regulatory Affairs Specialist OpportunityAn exciting opportunity has arisen for a skilled Regulatory Affairs Specialist to join the patient safety team within the Transformation Directorate's Digital Clinical Informatics (DCI) team at NHS England.The role will support the quality and regulatory team in implementing and maintaining NHS-England's quality...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecules. This is a unique opportunity to showcase your technical skills, specialist...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecules. This is a unique opportunity to showcase your technical skills, specialist...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Senior Regulatory Affairs Manager/ConsultantWe are seeking a seasoned Senior Regulatory Affairs Manager/Consultant to join our team at Lifelancer. As a key member of our regulatory affairs team, you will be responsible for providing expert guidance on regulatory strategies, ensuring compliance with EU guidelines, and managing client relationships.This is a...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Senior Regulatory Affairs Manager/ConsultantWe are seeking a seasoned Senior Regulatory Affairs Manager/Consultant to join our team at Lifelancer. As a key member of our regulatory affairs team, you will be responsible for providing expert guidance on regulatory strategies, ensuring compliance with EU guidelines, and managing client relationships.This is a...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecules. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecules. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Leeds, Leeds, United Kingdom William Hill Full time

    Senior Regulatory Affairs SpecialistWe are seeking an experienced professional to lead our regulatory affairs efforts. As a Senior Regulatory Affairs Specialist, you will be responsible for ensuring that our company adheres to all relevant regulations, industry standards, and internal policies.Key Responsibilities:Oversee compliance strategies and coordinate...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Leeds, Leeds, United Kingdom William Hill Full time

    Senior Regulatory Affairs SpecialistWe are seeking an experienced professional to lead our regulatory affairs efforts. As a Senior Regulatory Affairs Specialist, you will be responsible for ensuring that our company adheres to all relevant regulations, industry standards, and internal policies.Key Responsibilities:Oversee compliance strategies and coordinate...

  • Regulatory Affairs Specialist

    1 week ago

    Leeds, Leeds, United Kingdom Seven Life Sciences Full time

    **Job Title:** Regulatory SpecialistAt Seven Life Sciences, we are seeking a highly skilled Regulatory Specialist to join our Quality and Regulatory team. The successful candidate will be responsible for maintaining compliance with ISO 13485, Medical Device Directive 93/42/EEC, and Regulation (EU) 2017/745 (EU MDR).**Key Responsibilities:**Review, update,...

  • Regulatory Affairs Specialist

    4 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Job Title: Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong regulatory affairs experience,...

  • Regulatory Affairs Specialist

    4 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Job Title: Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong regulatory affairs experience,...

  • Regulatory Affairs Specialist

    4 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Job Title: Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong regulatory affairs experience,...

  • Regulatory Affairs Specialist

    4 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Job Title: Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong regulatory affairs experience,...

  • Regulatory Affairs Specialist

    4 weeks ago

    Leeds, Leeds, United Kingdom Pharmiweb Full time

    Regulatory Affairs ProfessionalWe are seeking a highly skilled Regulatory Affairs Professional to join our team at Pharmiweb. As a key member of our regulatory team, you will be responsible for providing leadership in all regulatory and submissions-related aspects of clinical trials.Key Responsibilities:Provide guidance on submissions strategies and ensure...

  • Regulatory Affairs Specialist

    4 weeks ago

    Leeds, Leeds, United Kingdom Pharmiweb Full time

    Regulatory Affairs ProfessionalWe are seeking a highly skilled Regulatory Affairs Professional to join our team at Pharmiweb. As a key member of our regulatory team, you will be responsible for providing leadership in all regulatory and submissions-related aspects of clinical trials.Key Responsibilities:Provide guidance on submissions strategies and ensure...

Regulatory Affairs Specialist

2 months ago

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

We are seeking a highly skilled and experienced Qualified Person to join our team at MAC Clinical Research. As a key member of our organization, you will play a critical role in ensuring the quality and safety of our clinical trials.

Key Responsibilities
  • Certify Investigational Medicinal Products (IMPs) under our MIA IMP license, adhering to Directive 2001/20/EC Article 13.
  • Perform duties as described in Article 51 of Directive 2001/83/EC and applicable UK Statutory Instruments.
  • Release IMPs for use in human clinical trials at MAC Clinical Research facilities, ensuring subject safety.
  • Ensure compliance with MIA IMP and maintain a robust Quality Management System.
  • Oversee GMP compliance, perform audits, and conduct training sessions as required.
  • Interpret and communicate new regulations, and ensure their incorporation into procedures.
  • Participate in incident, deviation, and CAPA management, and undertake Continuing Professional Development.
  • Maintain professional qualifications, adhere to QP code of practice, and comply with MAC health and safety policy.
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 of experience in clinical trials within the pharmaceutical industry.
  • Experience in CRO, Phase 1 Unit, or Hospital pharmacy.
  • Eligibility to act as QP and be named on MIA IMP License.
What We Offer
  • Competitive salary in line with pharmaceutical industry standards.
  • Health Insurance.
  • Free onsite parking.
  • 25 days annual leave (increasing to 30 days after 6 years' service).
  • Your birthday off work.
About MAC Clinical Research

MAC Clinical Research is a full-service global Contract Research Organisation (CRO) with a network of research sites. We are committed to serving with honesty and integrity to make an outstanding contribution to human health.