Head of Regulatory Affairs

2 weeks ago


Liverpool, Liverpool, United Kingdom Proclinical Full time
Proclinical are partnering with a CRO who are recruiting for an individual to join their team.

This role is on a permanent basis and the opening position that is available is for a Head of Regulatory Affairs.

***
Responsibilities:
  • Provides strategic regulatory input to all assigned projects.
  • Management, preparation, assembly of the Master Core Dossier and submissions of European:
  • Clinical Trial Authorisation Applications (CTAA) and amendments
  • Countrylevel Informed Consent and other patient facing documentation.
  • Tracks, reports and files CTAA and amendment submissions/approval progress in electronic trial master files (eTMF) clinical trials management system (CTMS) or other applicable systems.
  • Proactively provides strategic direction to the client on regulatory specific issues and provides associated mitigation as required.
  • Participates in the quality control (QC) steps involved for all the above.
  • Serves as key regulatory liaison for multicontinental project. Liaison with other departments, including Data Management, Medical Writing Pharmacovigilance, Quality Assurance and Drug Distribution.
  • Maintains metrics on a monthly basis of all regulatory submissions.
  • Strategic crossfunctional interaction with a variety of departments to provide EU regulatory solutions to problems including the management of timelines to complete regulatory submissions on time
  • Responsible for providing assistance to perform effectively the
- planning, critical reviews and scientific writing of a number of regulatory activities such as IMPDs, DSURs, study protocols, IBs and patient information sheets in order to successfully obtain the regulatory approval.

  • Validate and provide input into our clients' regulatory development strategies, support our clients in preparing for and obtaining scientific advice from EU Competent Authorities and the EMA and prepare Orphan Drug Applications where required.
  • Supports clients in preparing for advice meetings with national RAs or the European Medicines Agency.
  • Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by IECs and CA's.
  • Supports Regulatory Director in business development activities including the preparation of client proposals and bid defense meetings.
  • Provides regulatory training to other members of the team as required.

Key Skills and Requirements:

  • Bachelor's degree required preferably in a life science field or equivalent
  • Be informed and aware of European and US Regulatory developments.
  • Knowledge of oncology study endpoints
  • Detailed knowledge of ICH-GCP/FDA requirements
  • Excellent interpersonal skills
  • Proven ability to demonstrate problem solving skills.
  • Proven ability to meet deadlines.
  • Strong communication skills: verbal/written.
  • Highly organized and resultoriented
  • Good knowledge of Windowsbased software programs


Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

LI-HQ1

CRODelivery

Regulatory

  • Liverpool, Liverpool, United Kingdom Thornshaw Scientific Recruitment Full time

    Posted date 01 February 202- LocationMerseyside Job type Contract SalaryNegotiable Discipline Life Sciences ReferenceJO Work Location HybridRegulatory Affairs Senior Associate6 month contractLiverpool based - Hybrid working with 3 days onsiteOffering up to £40.00 Per Hour via PAYEStrong potential for extensionCPL Life Sciences is collaborating with a...


  • Liverpool, Liverpool, United Kingdom Regulatory Professionals Full time

    Reference Number: JO Quality Assurance AssociateRate: NegotiableJob Type: ContractLocation: Moreton, MerseysideQuality Assurance Associate l12 Month Contract£19.23 per hour PAYE, 35 hours per weekMerseyside - 50/50 Hybrid workingKey Responsibilities Project Manage/support the External QP release process. Coordinate/align on all required documentation....

  • Head Of Department

    2 weeks ago


    Liverpool, Liverpool, United Kingdom University of Liverpool - Faculty of Humanities and Social Sciences - School of Histories, Languages Full time

    Chair and Head of the Department of Politics The School of Histories, Languages and Cultures wishes to appoint a Head of Department in Politics. The role of Head of Department will be fixed term until initially and will be offered in combination with a permanent post at Professorial level. You will be an inspirational academic leader, with a clear vision...

  • Head of Quality

    2 weeks ago


    Liverpool, Liverpool, United Kingdom Surface Transforms Full time

    Head of QualityJoin Us at Surface TransformsSurface Transforms specialize in the advancement and manufacture of carbon-ceramic materials and are the only UK company producing carbon-ceramic brakes for cars. Our patented Carbon-Ceramic technology guarantees top-notch braking performance both on the road and the track.Passion drives everything we do at Surface...


  • Liverpool, Liverpool, United Kingdom Planet Pharma Full time

    Title: Downstream Process Scientist Type: Contract Length: 6 Month (Likely Extension) We've currently partnered with a with a global large scale pharmaceutical manufacturing company who are now looking for a talented Downstream Process Development Scientist to join their R&D team. This is a 6 month contract based full tie in Liverpool Key Responsibilities: ...

  • Head of Governance

    2 weeks ago


    Liverpool, Liverpool, United Kingdom School Improvement Liverpool Full time

    Head of Governance Job Title: Head of Governance Employer: St Joseph Catholic Multi Academy Trust Job Type: Finance & Administration Job Phase: N/A Grade: Competitive Contract Type: Permanent Contract Term: Full time Location: Liverpool Start Date: Start immediately Closing Date: Monday, June 17th, 2024 About the School St Joseph...


  • Liverpool, Liverpool, United Kingdom University of Liverpool Full time

    The Finance department is seeking to appoint a Head of Finance Systems.This a critical role within the Finance department, as it focuses on optimising system usage and supporting change initiatives. The university is currently in the process of migrating its ERP system (Unit4) to the cloud with the aims of enhancing efficiency, accessibility, and scalability...

  • Head of HR

    2 weeks ago


    Liverpool, Liverpool, United Kingdom Sefton Council Full time

    Sefton is a vibrant local authority on a journey of aspiration and ambition as it works towards delivering its exciting Vision 2030. This journey is shared with our partners and communities as we strive to ensure Sefton is a confident and connected Borough. indeed, the borough is internationally recognised for its outstanding natural beauty and commitment to...


  • Liverpool, Liverpool, United Kingdom Planet Pharma Full time

    Job Title: Strategic Director Clinical Operations at Global BiotechType: Permanent / Full timeCompany: Global BiotechLocation: RemotePlanet Pharma has partnered with a leading Global Biotech based in Europe. They are in need of an experienced Director/Program Lead to oversee and drive their clinical operations development efforts. As the Strategic Director,...


  • Liverpool, Liverpool, United Kingdom BCL Legal Full time

    PSL Healthcare SolicitorAn award winning national law firm are looking for an experienced Healthcare Solicitor to join their national team. THE ROLEAn experienced Professional Support Lawyer (PSL) is sought to join the Healthcare Team at this leading firm.The role will involve the provision of market affairs and legal support for the Healthcare segment,...


  • Liverpool, Liverpool, United Kingdom University of Liverpool Full time

    We are looking for a creative, goal-driven marketing and communications professional to join our growing team at the University of Liverpool.The Head of Supporter and Alumni Communications is a new role that is pivotal in supporting the Development and Alumni Relations team to create and deliver communication campaigns that will engage our global audiences...


  • Liverpool, Liverpool, United Kingdom University of Liverpool Full time

    This role offers an exciting opportunity to work within the Faculty of Science and Engineering¿s Compliance and Operations Team. Reporting to the Safety, Risk and Compliance Manager (SRCM) and ultimately responsible to the Faculty Head of Compliance and Operations, your principal role will be to assist in providing monitoring, oversight and coordination of...

  • Head of Education

    2 weeks ago


    Liverpool, Liverpool, United Kingdom Liverpool John Moores University Full time

    We are seeking an exceptional individual to join our School of Education which has a long and proud history in education studies, SEND, childhood and community studies, teacher education and sector leading postgraduate provision. We have a reputation for outstanding graduates.You will be responsible for the School's Education and Early Childhood portfolio:...

  • Head of Tax

    2 months ago


    Liverpool, Liverpool, United Kingdom Hire Resolve Full time

    Hire Resolve's client is a large consulting firm, which is seeking a Head of Tax to join their team of professionals. This is an exciting opportunity to lead the tax department of a dynamic and growing company.Responsibilities:Develop and implement tax strategies to minimize tax liabilities Manage and oversee all tax compliance processes, including tax...


  • Liverpool, Liverpool, United Kingdom Accountable Recruitment Full time

    Group Head of Financial Reporting / Liverpool (Hybrid working) / Salary circa £90,000 plus a range of other great company benefits.We have a fantastic opportunity for an experienced Group Head of Financial Reporting and Compliance to join our clients established Finance team in Liverpool.Key responsibilities:Responsible for the production of group wide...


  • Liverpool, Liverpool, United Kingdom University of Liverpool Full time

    This role offers an exciting opportunity to work within the Faculty of Science and Engineering's Compliance and Operations Team. Reporting to the Safety, Risk and Compliance Manager (SRCM) and ultimately responsible to the Faculty Head of Compliance and Operations, your principal role will be to assist in providing monitoring, oversight and coordination of...


  • Liverpool, Liverpool, United Kingdom University of Liverpool Full time

    This role offers an exciting opportunity to work within the Faculty of Science and Engineering's Compliance and Operations Team. Reporting to the Safety, Risk and Compliance Manager (SRCM) and ultimately responsible to the Faculty Head of Compliance and Operations, your principal role will be to assist in providing monitoring, oversight and coordination of...


  • Liverpool, Liverpool, United Kingdom University of Liverpool Full time

    We are seeking to appoint an experienced administrator who will work closely with the DTP Manager to provide administrative support and coordination for student recruitment, student support, and ensuring accurate record management.You must be a capable communicator who enjoys working with a broad range of stakeholders (PhD students, academic leads, non-HEI...

  • Head of Management

    2 weeks ago


    Liverpool, Liverpool, United Kingdom The Liverpool Institute of Performing Arts Full time £52,815 - £59,421

    The Liverpool Institute for Performing Arts is recognised as a world leading centre of excellence for creative learning and vocational training within the performing arts and creative economies. To align with our vision and values, our ambitious strategic plan focusses on the core themes of Excellence, Equity, Environment, Empowerment, Employability and...

  • Head of Management

    2 weeks ago


    Liverpool, Liverpool, United Kingdom The Liverpool Institute of Performing Arts Full time

    The Liverpool Institute for Performing Arts is recognised as a world leading centre of excellence for creative learning and vocational training within the performing arts and creative economies.To align with our vision and values, our ambitious strategic plan focusses on the core themes of Excellence, Equity, Environment, Empowerment, Employability and...