Current jobs related to Clinical Data Disclosure and Regulatory Affairs Specialist - London, Greater London - Lifelancer

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA rare chance to start your career in chemical regulatory affairs with VRS Regulatory, a specialist scientific recruiter.About the Role:As a Regulatory Affairs Specialist, you will work under the supervision of an experienced regulatory manager, providing regulatory support to a wide range of chemical products. You will be...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA rare chance to start your career in chemical regulatory affairs with VRS Regulatory, a specialist scientific recruiter.About the Role:As a Regulatory Affairs Specialist, you will work under the supervision of an experienced regulatory manager, providing regulatory support to a wide range of chemical products. You will be...

  • Regulatory Affairs Specialist

    2 months ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA unique chance to launch your career in chemical regulatory affairs with VRS Regulatory, a specialist scientific recruiter.About the Role:Work under the guidance of an experienced regulatory manager to provide support for a diverse range of chemical products.Conduct a variety of activities, including SDS authoring, updates,...

  • Regulatory Affairs Specialist

    2 months ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA unique chance to launch your career in chemical regulatory affairs with VRS Regulatory, a specialist scientific recruiter.About the Role:Work under the guidance of an experienced regulatory manager to provide support for a diverse range of chemical products.Conduct a variety of activities, including SDS authoring, updates,...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kickstart your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support for a wide range of chemical products.Conduct a range of activities, including SDS authoring,...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kickstart your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support for a wide range of chemical products.Conduct a range of activities, including SDS authoring,...

  • Regulatory Affairs Specialist

    2 months ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Job DescriptionA rare opportunity for an aspiring regulatory affairs professional to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive trainingAn excellent opportunity to start and establish...

  • Regulatory Affairs Specialist

    2 months ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Job DescriptionA rare opportunity for an aspiring regulatory affairs professional to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive trainingAn excellent opportunity to start and establish...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA rare chance to start your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support to a wide range of chemical products.Conduct a range of activities to support a broad product portfolio,...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA rare chance to start your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support to a wide range of chemical products.Conduct a range of activities to support a broad product portfolio,...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kick-start your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support to a wide range of chemical products.Conduct a range of activities to support a broad product...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kick-start your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support to a wide range of chemical products.Conduct a range of activities to support a broad product...

  • Clinical Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom Clinical Professionals Limited Full time

    Medical Information Specialist - Clinical RegulatoryWe are seeking a highly skilled Medical Information Specialist to join our team at Clinical Professionals Limited. As a Medical Information Specialist, you will play a crucial role in providing accurate and timely medical information to support the development and marketing of our pharmaceutical...

  • Clinical Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom Clinical Professionals Limited Full time

    Medical Information Specialist - Clinical RegulatoryWe are seeking a highly skilled Medical Information Specialist to join our team at Clinical Professionals Limited. As a Medical Information Specialist, you will play a crucial role in providing accurate and timely medical information to support the development and marketing of our pharmaceutical...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kickstart your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the guidance of an experienced regulatory managerProvide regulatory support for a diverse range of chemical productsParticipate in ongoing and comprehensive trainingYou will be...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kickstart your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the guidance of an experienced regulatory managerProvide regulatory support for a diverse range of chemical productsParticipate in ongoing and comprehensive trainingYou will be...

  • Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Specialist - Chemical Compliance ExpertWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at VRS Regulatory. As a key member of our regulatory affairs team, you will be responsible for providing expert advice on chemical regulatory compliance and ensuring that our clients' products meet the necessary regulatory...

  • Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Specialist - Chemistry/Analytical MethodsWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at VRS Regulatory. As a key member of our regulatory affairs team, you will be responsible for providing expert advice on substance and product registrations strategies, reviewing phys-chem data packages, and facilitating...

  • Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Specialist OpportunityVRS Regulatory is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for providing regulatory advice to clients in the chemical regulatory science consultancy sector.Key Responsibilities:Providing clients with regulatory...

  • Regulatory Affairs Specialist

    1 week ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Career OpportunityVRS Regulatory is seeking a highly skilled Regulatory Affairs Specialist to join our team in delivering regulatory services related to chemistry and analytical methods for plant protection products.Key Responsibilities:Provide regulatory advice to clients on substance and product registrations strategies.Review phys-chem...

Clinical Data Disclosure and Regulatory Affairs Specialist

2 months ago

London, Greater London, United Kingdom Lifelancer Full time
About the Role

We are seeking a highly skilled Data Transparency and Regulatory Disclosure Manager to join our team at Lifelancer. As a key member of our organization, you will be responsible for driving the end-to-end processes of disclosure activities for assigned asset portfolios, ensuring timely and accurate disclosure of Ipsen clinical data on public websites.

Key Responsibilities
  • Disclosure Management
    • Provide specialized knowledge of global disclosure requirements and standards to study/asset teams, ensuring quality and confidentiality of information shared publicly.
    • Assess the applicability of clinical studies and submission dossiers for disclosure in accordance with US EU laws and other applicable regulations or policies.
    • Ensure study disclosure assessment is tracked and filed, and disclosure roadmap shared with relevant stakeholders in a timely manner.
    • Review study protocols, study documents, and product-related documents to identify confidential information and determine its suitability for disclosure.
  • Vendor Management and Budgeting
    • Be accountable for and oversight work delegated to preferred vendors.
    • Plan budget needs per each outsourced activity.
    • Ensure optimal outsourcing strategy for disclosure activities by partnership with procurement and in alignment with top management.
  • Regulatory Compliance and Awareness
    • Perform a regulatory watch on disclosure and transparency requirements from agencies, industry associations, and communities.
    • Contribute to relevant industry communities.
    • Perform benchmark activities and monitor emergences of standards in this area.
  • Global Operational Excellence Support and Transversal Activities
    • Participate or lead process improvement and digitalization/automation initiatives that promote strategic disclosures and operational excellence.
    • Contribute to the development and maintenance of Standard Operating Procedures and other documentation to ensure effective implementation of processes.
    • Mentor more junior staff members.
Requirements
  • Education/Certifications
    • Bachelor's or Master's degree in life sciences.
    • Preferred: Master or PhD graduated in a discipline relevant to the pharmaceutical industry.
  • Experience
    • At least 35 years of experience in clinical data disclosure/transparency, regulatory affairs, clinical operations, or consulting for RD projects in the pharmaceutical industry.
    • Good understanding of RD environment and drug development process.
    • Well-versed in preparing or reviewing clinical and/or regulatory documents and/or experience in summarizing scientific information.
  • Technical Skills
    • Proficiency with Microsoft Word, Excel, PowerPoint, and other Office applications.
    • Experience working on platforms like Sharepoint, Drive, Teams, etc.
    • Ability to work effectively with electronic document management system (eDMS) and trial master file (eTMF).