Manager, eLabeling – Business Outcomes Delivery (ePI/ Digital Labeling) – M/K

Aplikuj.pl; Warszawa; Híbrido; PLN 60 000 - 80 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Private healthcare

Sports card

Insurance

Resumo da oferta

Students is seeking a professional in Warsaw, Poland, to enhance regulatory affairs through structured digital labeling solutions. You will support initiatives aimed at improving labeling processes while collaborating across diverse teams.

The ideal candidate should have a Bachelor’s degree and 3-4+ years of experience in related fields, along with strong analytical skills. Offering hybrid work and a comprehensive benefits package, this position allows for engagement in global digital transformation initiatives.

Qualificações

• 3-4+ years of experience in Regulatory Affairs or similar.
• Experience with regulatory submissions and medical information.
• Experience in cross-functional, international environments.

Responsabilidades

• Support rollout and adoption of structured eLabeling solutions.
• Drive continuous improvement of digital labeling processes.
• Analyze workflows for process optimization.

Conhecimentos

Regulatory Affairs

Analytical skills

Stakeholder management

Fluent English

Project management

Formação académica

Bachelor’s degree

Ferramentas

eLabeling systems

AI-based tools

Descrição da oferta de emprego

Responsibilities

• Support the rollout and adoption of structured eLabeling solutions (ePI, FHIR, IDMP)
• Drive continuous improvement of structured authoring platforms and digital labeling processes
• Collaborate with business, technical teams, and vendors to deliver scalable digital solutions
• Translate business and regulatory needs into clear, structured requirements and acceptance criteria
• Analyze workflows and identify opportunities for process optimization and standardization
• Support product roadmap execution and ensure alignment across global stakeholders
• Contribute to system adoption, change management, and continuous improvement initiatives
• Participate in global projects and support audit and inspection readiness
• Communicate with international stakeholders and explain complex topics in a clear and concise way

Qualifications

• Bachelor’s degree or equivalent experience
• 3‑4+ years of experience in Regulatory Affairs, Regulatory Operations, Quality Systems, or similar
• Experience in labeling, regulatory submissions, Medical Information, or CMC
• Strong analytical skills with a process improvement mindset
• Ability to translate business needs into structured, testable requirements
• Experience working in cross‑functional, international environments
• Strong communication and stakeholder management skills
• Fluent English
• Experience with eLabeling, structured authoring, or digital transformation initiatives
• Knowledge of FHIR, IDMP, or ePI standards
• Experience with modern digital tools, including AI‑based solutions
• Project management experience or certification

Benefits

• Direct employment with a global pharmaceutical organization
• Hybrid work model (Poland‑based)
• Opportunity to contribute to global digital transformation initiatives
• Work in an international, cross‑functional environment
• Exposure to modern technologies used in regulatory processes
• Professional development within global structures
• Attractive benefits package (private healthcare, sports card, insurance)
• The offer applies to permanent work