mazowieckie / Warszawa
Regulatory Affairs Publishing Specialist
2025-06-12
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!
Regulatory Affairs Publishing Specialist
Miejsce pracy: Warszawa
Nr Ref.: 19473
Job Tasks:
The offer applies to permanent work.
- 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
The offer applies to permanent work.