179300 zł PLN - 217268 zł PLN
... Regulatory precedents as requested in collaboration with Portfolio Acceleration & Analytics team to share at GRT to assess health authority trend analyses - Global Regulatory Submissions Support - Support submission team BOW meetings e.g. data prepa ra tion to enhance GRT discussions - Maintanenace of Regulatory Information Management ...
Poland, Warszawa
Zobacz ofertę... regulatory affairs. This is a fully remote role with global exposure and frequent collaboration with life science teams. You will conduct gap analyses, develop regulatory strategies (CMC, INDs, BLAs), support submissions, and prep clients for agency interactions. A PhD/MS and 5+ years in biopharma are required, with travel as ...
Poland, Warząchewka Polska
Zobacz ofertę- Zdalnie
- Hybrydowo
- Stacjonarnie
- Kontrakt
... metrics against targets/timelines (at a project/country/site level) - Provide operational oversight to SSU Associates on assigned projects - Responsible for all submissions and obtaining approval from IRB/ECs (incl CTIS Part 2 package); - May be responsible for submissions to Regulatory Authorities in non-EU countries (ex. UK, ...
Poland, Warząchewka Polska
Zobacz ofertę11k
... taking care of any linked filing obligations - Providing assistance to the direct client servicing teams (handling the day-to-day client work) with their regulatory questions and requests - Acting as the local point of contact for international regulatory projects involving other TMF offices in several different jurisdictions ...
Poland, Katowice
Zobacz ofertęZakres obowiązków: - przygotowywanie i aktualizacja dokumentacji rejestracyjnej dla suplementów diety, wyrobów medycznych oraz kosmetyków, - opracowywanie i kompletowanie dokumentacji technicznej wyrobów medycznych, - prowadzenie procesów rejestracyjnych na rynkach Unii Europejskiej oraz poza UE, - analiza wymagań
Poland, Warszawa
Zobacz ofertę- Zdalnie
- Hybrydowo
- Stacjonarnie
172296 zł PLN - 258444 zł PLN / year
172296 - 258444 zł / rocznie
This role can be either home or office-based in Warsaw. LI-REMOTE
Praca zdalna
Praca z domu
Poland, Kraków
Zobacz ofertę... daily playground will involve: - Stakeholder Data Management: Coordinate and manage data inputs from various internal and external stakeholders, ensuring all submissions are timely and complete. - Data Validation & Accuracy: Review, verify, and clean all data submitted to payroll to guarantee maximum accuracy before final ...
Poland, Wrocław
Zobacz ofertę- Zdalnie
- Hybrydowo
- Stacjonarnie
- Pełny etat
205850 zł PLN - 249445 zł PLN
... **Manager, Global Scientific and Regulatory Documentation - based in Warsaw - l**eads document strategy and authoring of message-driven, clear and concise regulatory documents in support of submissions and approvals in key markets and other geographies. Provides support for fit-for-purpose regulatory documents (clinical ...
Poland, Warszawa
Zobacz ofertę- Zdalnie
- Hybrydowo
- Stacjonarnie
- Pełny etat
230560 zł PLN - 279377 zł PLN
... **Senior Manager, Global Scientific and Regulatory Documentation - based in Waesaw - l**eads document strategy and authoring of message-driven, clear and concise regulatory documents in support of submissions and approvals in key markets and other geographies. Provides support for fit-for-purpose regulatory documents (clinical ...
Poland, Warszawa
Zobacz ofertę... daily playground will involve: - Stakeholder Data Management: Coordinate and manage data inputs from various internal and external stakeholders, ensuring all submissions are timely and complete. - Data Validation & Accuracy: Review, verify, and clean all data submitted to payroll to guarantee maximum accuracy before final ...
Poland, Wrocław
Zobacz ofertę- Zdalnie
- Hybrydowo
- Stacjonarnie
- Pełny etat
174980 zł PLN - 212026 zł PLN
... continuous improvement workstreams to enhance quality and increase efficiency of document processes, including automated and digital solutions for development of regulatory documentation.**Qualifications*** **Minimum of BS/BA degree with 4+ years of regulatory documentation experience in document management repositories, submission ...
Poland, Warszawa
Zobacz ofertęZakres obowiązków: - przygotowywanie i aktualizacja dokumentacji rejestracyjnej dla suplementów diety, wyrobów medycznych oraz kosmetyków, - opracowywanie i kompletowanie dokumentacji technicznej wyrobów medycznych, - prowadzenie procesów rejestracyjnych na rynkach Unii Europejskiej oraz poza UE, - analiza wymagań
Poland, Starogard Gdański
Zobacz ofertę... sites/studies. - Collection of essential documents from sites and completing quality check (ALCOA). - Compiling and submitting ethics and other required local submissions including customization of ICFs, patient facing materials and safety reporting. - Coordinating with Regulatory and CTS on CA submission and approval status ...
Poland, Warszawa
Zobacz ofertęREACH Regulatory Specialist Miejsce pracy: Łódź Your responsibilities - Collect, analyse, compile, and preparing data and documents to support Regulatory Affairs Team and ensure compliance of Flint Products globally - Support product development, enforcing current, relevant regulations and preparing organisation for upcoming ...
Poland, Gdańsk
Zobacz ofertę... processes, including the review of job costing, materials, and staff requirements. - Analyze blueprints and construction documents to provide accurate bid submissions. - Manage the bid submission process, including negotiations, award processes, and handling change orders. Business Management and Financial Consulting - ...
Poland, Warząchewka Polska
Zobacz ofertę... Associate will support the Europe West Data Risk/DSO team in operationalizing AI governance across the region. The role focuses on translating global AI policies, regulatory expectations and AI risk control requirements into practical guidance, monitoring routines, stakeholder support and governance oversight for Europe West AI ...
Poland, Poznań
Zobacz ofertę... that output meets the expected results and is consistent with analysis described in the SAP and specifications. - May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical ...
Poland, Poznań
Zobacz ofertę... Preferred Qualifications - Advanced scientific, life sciences, or related educational background - Experience supporting clinical trial documentation and regulatory submissions - Familiarity with clinical document review, quality control, publishing, and approval workflows - Experience collaborating within cross functional ...
Poland, Kraków
Zobacz ofertę- Zdalnie
- Hybrydowo
- Stacjonarnie
This is a client dedicated project, and the role can be office or home based in various European locations. LI-REMOTE
Praca zdalna
Praca z domu
Poland, Kraków
Zobacz ofertę- Zdalnie
- Pełny etat
- Część etatu
- Kontrakt
151200 zł PLN - 280700 zł PLN / year
151200 - 280700 zł / rocznie
Contribute to site contract negotiations and feasibility assessments (preferred but not mandatory). Contract negotiation experience. Location; and/or schedule (full or part-time), Poland | Home-Based. Ability to work independently in a remote environment.
Poland, Kwidzyn
Zobacz ofertę