Informacje o stanowisku

Manpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i doświadczeniu. Skontaktuj się z nami - to nic nie kosztuje, możesz za to zyskać profesjonalne doradztwo i wymarzoną pracę!Job Tasks:

• Navigate through systems and tools to assemble, publish, validate, dispatch, and archive complex regulatory submissions in both paper and electronic formats, adhering to internal processes and regulatory guidelines, with a high level of independence
  
  
• Provide component-level publishing support for regulatory deliverables in PDF format, ensuring compliance with submission standards (e.g., bookmarking, linking, PDF versioning)
  
  
• Apply regulatory submission standards, requirements, processes, and policies to ensure adherence to internal and external health agency guidelines
  
  
• Maintain timely and effective communication with publishing contributors and responsible regulatory affairs professionals
  
  
• Provide technical guidance to submission contributors on submission requirements, standards, and processes to facilitate efficient processing by regulatory agencies
  
  
• Manage multiple complex submissions simultaneously, working with a high degree of independence
  
  
• Interpret and enforce paper and electronic submission standards, policies, and operating procedures
  
  
• Collaborate closely with various departments within Regulatory Affairs to ensure smooth processes
  
  

• Proficiency in using Regulatory Information Systems, planning, and/or publishing tools
  
  
• In-depth knowledge and experience with various submission and application types, publishing templates, and relevant regulatory agency and industry guidelines
  
  
• Strong project or submission management skills
  
  
• Deep understanding of therapeutic areas and the product development process
  
  
• Fluency in English
  
  
• Ability to work or lead in a matrix environment
  
  
• Strong interpersonal, teamwork, networking, and communication skills
  
  
• Ability to influence and develop work practices, standards, and procedures across the organization
  
  
• Capability to coach and mentor colleagues on applicable guidelines, standards, and publishing requirements
  
  

• Opportunity to join a global team and contribute to innovative projects in international markets
  
  
• Option for 100% remote work within Poland
  
  
• Work primarily in English within a dynamic, international team
  
  
• Competitive salary
  
  
• Benefits package including healthcare, sports card, and insurance
  
  

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