Regulatory Affairs Specialist

1 tydzień temu


Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat

We are seeking a highly skilled Senior Regulatory Specialist to join our team at 9605 GSK Services Sp z o.o. The ideal candidate will have expertise in regulatory affairs with a focus on CTA/IND lifecycle strategy development and execution.

Key Responsibilities:

  • Develop and refine CTA/IND lifecycle strategies to ensure timely content delivery and compliance with GSK policy and procedures.
  • Coordinate with cross-functional teams to ensure effective communication and delivery of regulatory submissions.
  • Manage and maintain accurate records of regulatory submissions and compliance.

Requirements:

  • Minimum Bachelor's degree in biological or healthcare science.
  • Relevant experience within Regulatory Affairs in the R&D, pharmaceutical industry or clinical trials.
  • Strong understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
  • Excellent communication and interpersonal skills to work effectively in a matrix environment.

About Us:

GSK is a global biopharma company dedicated to uniting science, technology, and talent to get ahead of disease together. We offer a dynamic and inclusive work environment that fosters growth and development.



  • Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat

    Senior Regulatory Affairs SpecialistWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at 9605 GSK Services Sp z o.o. in Poland.Key Responsibilities:Develop and implement the CTA/IND lifecycle strategy, ensuring timely content delivery and compliance with GSK policy and procedures.Coordinate with internal teams to ensure...


  • Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat

    Job Title: Regulatory SpecialistAs a Regulatory Specialist at 9605 GSK Services Sp z o.o., you will play a crucial role in supporting operational activities related to the maintenance of marketing authorizations (MAs) across assigned markets and/or submission types in European Partnership Markets.Key Responsibilities:Support country leads in activities...


  • Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat

    Job Title: Senior Regulatory Specialist, CTA/INDJob Summary:We are seeking a Senior Regulatory Specialist to join our Polish Hub. The successful candidate will be responsible for coordinating, developing and refining the CTA/IND lifecycle strategy, ensuring timely content delivery and compliance with GSK policy and procedures.Key Responsibilities:Develop and...


  • Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat

    Role OverviewThe Regulatory Specialist will support operational activities related to maintenance of marketing authorizations (MAs) across assigned markets and/or submission types in European Partnership Markets, working in close collaboration with country leads, as well as global regulatory teams/centers and local 3 party service providers, if...


  • Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat

    Job Title: Senior Regulatory Specialist, New Registration CMCGlobal Regulatory Centres (GRC) in GSK are regulatory affairs functions which bring together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, licence maintenance and lifecycle management dossiers, and...


  • Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat

    Job Overview9605 GSK Services Sp z o.o. is seeking a highly skilled Regulatory Specialist to join our New Registration CMC Team. As a key member of our team, you will play a crucial role in ensuring the safety, efficacy, and quality of our pharmaceutical and vaccine products.Key ResponsibilitiesManage multiple CMC new files and CTA assignments for...


  • Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat

    Job Title: Regulatory Project ManagerWe are seeking a highly skilled Regulatory Project Manager to join our team at 9605 GSK Services Sp z o.o. The successful candidate will be responsible for ensuring the development of regulatory strategies and their execution for assigned assets, consistent with the strategic activities for GSK's Classic & Established...


  • Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat

    Our TeamGlobal Regulatory Centres (GRC) in GSK are regulatory affairs functions which bring together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, licence maintenance and lifecycle management dossiers, and regulatory information management.The Global...


  • Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat

    Job SummaryAs a Senior Regulatory Specialist - Country Labelling, you will be responsible for effective coordination, communication, and maintenance of regional/country labelling documents and data in regulatory systems.Key ResponsibilitiesAuthor and compile Regional/Country Product Information as per regulatory authority labelling requirements and GSK...


  • Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat

    Job Title: Senior Regulatory Specialist, Country LabellingAbout the Role:We are seeking a highly skilled Senior Regulatory Specialist, Country Labelling to join our team at 9605 GSK Services Sp z o.o. The successful candidate will be responsible for effective coordination, communication, and maintenance of regional/country labelling documents and data in...


  • Poznań, Greater Poland ROCKWOOL Group Pełny etat

    About the RoleWe are seeking a highly skilled Life Cycle Assessment Specialist to join our Group Regulatory Affairs team in Poznań, Poland. As a key member of our team, you will play a crucial role in supporting our sustainability agenda and contributing to the development of innovative stone wool solutions.Key ResponsibilitiesConduct Life Cycle Assessments...


  • Poznań, Greater Poland ROCKWOOL Group Pełny etat

    Life Cycle Assessment SpecialistWe are seeking a highly skilled Life Cycle Assessment Specialist to join our Group Regulatory Affairs team in Poznań, Poland. As a key member of our team, you will play a crucial role in supporting our sustainability agenda and contributing to the development of innovative stone wool solutions.About the RoleAs a Life Cycle...


  • Poznań, Greater Poland Ikea Pełny etat

    About the RoleAs a GBO P&C Knowledge Management Specialist, you will be responsible for implementing a knowledge management approach for P&C Services at GBO. This involves leading continuous improvement initiatives around knowledge management and working in partnership with GBO P&C Service teams and POT team.Key ResponsibilitiesImplement knowledge management...


  • Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat

    Job Title: Reporting SpecialistAt 9605 GSK Services Sp z o.o., we are seeking an experienced Reporting Specialist to join our team. As a Reporting Specialist, you will play a critical role in providing financial reporting and analysis to support business decision-making.Main Responsibilities:Financial Reporting: Prepare and review financial reports,...


  • Poznań, Greater Poland Ikea Pełny etat

    About the RoleAs a GBO P&C Knowledge Management Specialist, you will be responsible for implementing a knowledge management approach for P&C Services at GBO function. This role is part of the POT (People Operations Transformation) project, where you will lead the creation of service delivery model documentation for GBO and different countries. You will work...


  • Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat

    Key Responsibilities:As a Reporting Specialist at 9605 GSK Services Sp z o.o., you will be responsible for providing accurate and timely financial reports to support business decision-making. Your key responsibilities will include:Financial Reporting: Prepare and review financial reports, including balance sheet reconciliations, to ensure accuracy and...


  • Poznań, Greater Poland Islandsbanki Pełny etat

    About UsÍslandsbanki's Digital & Data department is a collaborative group of software development professionals who work together to deliver high-quality software solutions and capabilities. We believe in agile methodologies and cross-team synergy in product ideation and delivery.Job DescriptionWe are seeking a highly skilled Application Security Senior...


  • Poznań, Greater Poland LeasingTeam Group Pełny etat

    Job Title: Financial Controls SpecialistLeasingTeam Group, a leading personnel consultancy company, is seeking a highly skilled Financial Controls Specialist to join their team. As a key member of the Corporate Controlling Team, you will be responsible for ensuring the effective implementation of financial controls and risk management processes.Key...


  • Poznań, Greater Poland Perfect Gym Solutions Pełny etat

    Cloud Security SpecialistWe're seeking a skilled Cloud Security Specialist to join our team of specialists. In this role, you'll be responsible for defining, operating, and securing our cloud infrastructure.Your Key Responsibilities:Conception and implementation of security-related infrastructure topics and regulatory requirementsCommunication with risk and...


  • Poznań, Greater Poland LeasingTeam Group Pełny etat

    LeasingTeam Group is seeking a skilled Internal Controls Specialist to support the company's commitment to excellence in risk management and compliance.As a key member of the team, you will be responsible for ensuring that the control framework is consistent with regulatory requirements and best practices.The ideal candidate will have a strong background in...