Aktualne oferty pracy związane z Submission Expert - Warszawa, Mazovia - ManpowerGroup Sp. z o.o.

  • Biogen Center of Excellence Expert

    3 dni temu

    Warszawa, Mazovia, Polska Biogen, Inc. Pełny etat

    About the PositionWe are seeking an experienced professional to fill the role of Biogen Center of Excellence Expert at our office in Warsaw, Poland.This position involves supporting the ESE CoE Senior Analyst role within the GBS ESE and Sponsorship team, responsible for performing structured work assignments related to job discipline using existing...

  • ESE Process Improvement Expert

    7 dni temu

    Warszawa, Mazovia, Polska Biogen, Inc. Pełny etat

    ESE Process Improvement ExpertThe Biogen Senior Administrator will be responsible for improving the End-to-End process within the ESE tool, from submission of engagement through to closure. This includes identifying inefficiencies and implementing process improvements to increase efficiency and effectiveness.The ideal candidate will have a strong...

  • Regulatory Affairs Expert

    1 dzień temu

    Warszawa, Mazovia, Polska Tomasz Rutkowski Solo Law Firm Pełny etat

    **About the Role:**We are seeking a highly skilled Regulatory Affairs Expert to join our team. As a key member of our regulatory department, you will play a crucial role in ensuring compliance with all applicable regulations and guidelines.In this position, you will be responsible for the preparation and submission of clinical trial applications (CTAs)...

  • Tax Reporting and Compliance Expert

    1 tydzień temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    Role DescriptionWe are seeking a highly experienced Tax Reporting and Compliance Expert to join our team in Warsaw, Poland.The ideal candidate will have 5-6 years of experience in (indirect) tax compliance and reporting, with previous experience working with multinational corporations and ERP systems such as SAP.About the JobThis role is responsible for...

  • Regulatory Affairs Senior

    4 tygodni temu

    Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    For our Client, one of the biggest Pharmaceutical Companies worldwide, we are looking for a Regulatory Affairs Senior / Specialist in Submission Publishing who will be responsible for executing the electronic publishing of complex regulatory submissions for national, regional and global regulatory agencies and operating companies in both eCTD and non-eCTD...

  • Aerospace Solutions Expert

    6 dni temu

    Warszawa, Mazovia, Polska ADB Safegate Pełny etat

    We are looking for a seasoned Aerospace Solutions Expert to join our team at ADB Safegate. In this role, you will act as the initial technical point of contact, offering support or consultancy to our business. Your responsibilities will include providing quotations for solutions and services, ensuring that competitive pricing and cutting-edge technology are...

  • Senior Financial Analyst

    1 dzień temu

    Warszawa, Mazovia, Polska Johnson & Johnson Pełny etat

    Johnson & Johnson is a global leader in the pharmaceutical, medical device, and consumer packaged goods industries.We are seeking an EMEA Tax Reporting Expert to join our team. In this role, you will be responsible for supporting the preparation and submission of CIT tax returns for selected EMEA countries.Responsibilities:Support in the preparation and...

  • External Stakeholder Engagement Process Expert

    5 dni temu

    Warszawa, Mazovia, Polska Biogen Idec Pełny etat

    Job OverviewThe External Stakeholder Engagement Process Expert role at Biogen Idec is focused on ensuring the smooth operation of the External Stakeholder Engagement (ESE) process. This involves working closely with Engagement Owners to provide operational guidance and administrative support, maintaining electronic records, and resolving problems in...

  • regulatory affairs manager

    4 tygodni temu

    Warszawa, Mazovia, Polska Randstad Pełny etat

    Job SummaryA highly skilled Regulatory CMC Manager is sought to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products. This individual will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development.Key...

  • EMEA Tax Reporting Expert

    1 dzień temu

    Warszawa, Mazovia, Polska Johnson & Johnson Pełny etat

    We believe that our employees are our greatest asset, and we offer a range of benefits to support their growth and development.We are seeking a highly skilled professional to join our team as a Tax Compliance Specialist. In this role, you will be responsible for supporting the preparation and submission of CIT tax returns for selected EMEA countries.Key...

  • Clinical Publishing Expert

    5 dni temu

    Warszawa, Mazovia, Polska Indegene Pełny etat

    Key ResponsibilitiesIndependently perform compliance checks, publishing, and finalizing various clinical and regulatory documents as per the checklist, SOP, and HTG. Ensure finalized/published documents are submission-ready and comply with GCP, HRA, and other applicable international standards.Prepare electronic compilations in accordance with functional and...

  • Global ESE Operations Lead

    2 dni temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    About TN PolandRole OverviewWe are seeking a highly skilled ESE Center of Excellence Senior Analyst to join our Global Business Services (GBS) team. As a key member of the External Stakeholder Engagement (ESE) CoE team, you will be responsible for performing structured work assignments related to job discipline and using existing procedures and guidelines to...

  • External Stakeholder Coordinator

    5 dni temu

    Warszawa, Mazovia, Polska Biogen Idec Pełny etat

    Job OverviewThis role is part of the Global Business Services (GBS) ESE and Sponsorship team, supporting the end-to-end process within the ESE tool from submission through to closure. The Senior Analyst will provide operational guidance and administrative support to ensure on-time execution of external stakeholder engagements.Key Responsibilities:Supports...

  • Pharmaceutical Industry Expert

    1 tydzień temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    TN Poland is seeking a highly qualified Principal Regulatory Affairs Consultant to lead their regulatory affairs efforts in Warsaw.The successful candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval Chemistry, Manufacturing, and Controls (CMC) activities.This role offers a unique...

  • Regulatory Affairs Manager

    4 tygodni temu

    Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    Regulatory CMC ManagerWe are seeking a highly skilled Regulatory CMC Manager to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products.About the RoleIn this position, you will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and...

  • Regulatory Affairs Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    We are seeking a highly skilled Regulatory CMC Manager to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products. In this position, you will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development. This...

  • Regulatory Affairs Specialist

    6 dni temu

    Warszawa, Mazovia, Polska Rovensa Pełny etat

    Job DescriptionAs a Regulatory Affairs Specialist, you will be responsible for ensuring compliance and market access for Rovensa Next's innovative portfolio of biocontrol, bionutritional, and biostimulant products across Central East Europe. This includes securing and maintaining authorizations for fertilizers, biostimulants, and biocontrols in line with our...

  • Regulatory Affairs Expert

    1 tydzień temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    Parexel, a leading Clinical Research Organization (CRO), is seeking an experienced Principal Regulatory Affairs Consultant to join their team in Warsaw. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval Chemistry, Manufacturing, and Controls (CMC) activities.This is a...

  • Biocontrol Regulatory Expert

    6 dni temu

    Warszawa, Mazovia, Polska Rovensa Pełny etat

    About the RoleThis Regulatory Affairs Specialist position is ideal for an experienced professional who wants to contribute to the growth and success of Rovensa Next.In this role, you will be responsible for ensuring compliance and market access for our innovative portfolio of biocontrol, bionutritional, and biostimulant products across Central East...

  • Senior Manager Regulatory Affairs

    4 tygodni temu

    Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    Step into a pivotal role as Manager, Regulatory Affairs and contribute to the global development and lifecycle management of groundbreaking pharmaceutical products. As a key member of team, you will lead the development and execution of global CMC regulatory strategies, ensure compliance with regulatory requirements, and represent Global CMC Regulatory...

Submission Expert

1 tydzień temu

Warszawa, Mazovia, Polska ManpowerGroup Sp. z o.o. Pełny etat

We are seeking a highly skilled Regulatory Affairs Submissions Specialist to support our client specialized in pharma industry.

About the Client

The client is a global leader in the pharma industry, with a presence in over 70 countries and a portfolio of products that includes both prescription and over-the-counter medications.

Job Summary

The Regulatory Affairs Professional Submission Specialist will be responsible for ensuring compliance with regulatory agency regulations and interpretation, coordinating and compiling medium to complex dossier plans/submission packages, and may publish/dispatch.

Main Responsibilities
  • Collaborate with colleagues to ensure compliance with regulatory agency regulations and interpretation.
  • Coordinate and compile medium to complex dossier plans/submission packages.
  • May publish/dispatch.
  • Provide guidance to project team members.
  • Ensure that all required documents are included in the Dossier/Submission Package.
  • Perform a dossier review of the published output.
  • Track submission events/activities and timelines in appropriate systems/tools.
Requirements
  • In-depth understanding of the product development process.
  • Degree in pharmacy, bioscience or similar fields would be an asset.
  • Experience in in regulatory, medical, or pharmaceutical fields, or a background in information/library science.
  • Effective interpersonal, teamwork, and communication skills.
  • Ability to work or lead in a matrix environment.
  • Fluency in English.
  • Proficient use of Regulatory Information Systems, planning, and publishing tools.
What We Offer

We offer:

  • Opportunity to join a global team and work on global innovative projects.
  • Option for 100% remote job within Poland.
  • Work mainly in English within an international team.
  • Attractive salary.
  • ManpowerGroup Benefit Package: healthcare, sports card, possibility of joining group insurance, professional development program.