Informacje o stanowisku

Employer: ManpowerGroup Solutions Sp. z o.o.ZAKRES OBOWIĄZKÓW:
- Manage the planning, coordination, and delivery of regulatory submissions to global Health Authorities to support product development, registration, and lifecycle maintenance
- Develop and maintain Dossier Plans for assigned global submission types, incorporating input from cross‑functional stakeholders and ensuring alignment with agreed timelines and KPIs
- Coordinate submission activities across functions, including electronic publishing and dossier assembly, ensuring compliance with regional and country‑specific regulatory requirements
- Monitor submission progress, proactively identify risks or issues, and drive timely resolution in collaboration with Regulatory Affairs and publishing contributors
- Ensure timely dispatch and distribution of regulatory submissions to Health Authorities and/or Local Operating Companies, with accurate tracking in relevant systems and tools
- Apply applicable regulatory submission standards, processes, and policies to ensure compliance with health agency requirements
- Support continuous improvement of submission processes, including the development of work practices, process tools, and training documentation
- Contribute to compliance activities, special projects, and process optimization initiatives as required
WYMAGANIA:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field
- Proven experience in regulatory affairs, specifically in global submissions within the healthcare industry
- Strong understanding of international regulatory requirements and submission procedures
- Excellent organizational and project management skills with attention to detail
- Effective communication skills in English, both written and verbal
- Ability to work independently and collaboratively within a multidisciplinary team
- Proficiency in regulatory software and document management systems
- Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is advantageous
OFERUJEMY:
- Employment via Manpower based on an employment contract
- Flexible work arrangement: remote (outside Warsaw) or hybrid (Warsaw-based)
- Manpower Premium employment benefits including healthcare coverage
- Additional perks such as a Sport Card to support a healthy lifestyle
- Opportunities for professional development and career growth within a global organization
- Supportive and inclusive work environment in Warsaw, Poland
- Seize this opportunity to become a vital part of a forward-thinking healthcare organization

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