Global Regulatory Affairs Submission Specialist (NGS Unit) – M/K

Employer: ManpowerGroup Solutions Sp. z o.o.

Tasks:

• 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

Required Skills and Qualifications:

• 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

Offers:

• 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

Apply now to contribute to impactful projects and enjoy comprehensive benefits designed to enhance your professional and personal well-being. Join the team of our client and elevate your career in regulatory affairs today!