Regulatory Affairs Business Outcomes Delivery Manager (M/K)

For our client we are looking for a candidate for the position of Regulatory Affairs Business Outcomes Delivery Manager.

Responsibilities:

• Support the delivery of vision, strategy, and OKRs related to the rollout, enhancement, and maintenance of a global Translation Management System (TMS)
• Drive continuous improvement of the TMS platform and associated technologies to ensure accurate, consistent, and scalable translation outputs
• Lead the configuration and optimization of language assets, including translation memory, terminology, and dictionaries
• Translate business and regulatory needs into clear linguistic requirements, user stories, and acceptance criteria
• Analyze end‑to‑end workflows to identify bottlenecks, inefficiencies, and opportunities for standardization and process optimization
• Collaborate closely with business users, subject matter experts, product and technical teams, and other stakeholders to align priorities and deliver value
• Support system adoption initiatives, change management activities, and tracking of realized business benefits
• Participate in cross‑functional initiatives and support audit and inspection readiness activities

Requirements:

• University/Bachelor’s degree and 6-8 years of overall professional experience, including 3-4+ years in Regulatory Affairs, Regulatory Operations, Translation Operations, Quality Systems, or a GxP‑regulated environment
• Hands‑on experience working with a Translation Management System (TMS) and a strong understanding of translation operations, including cooperation with translation vendors and scaling delivery
• Practical experience managing language assets such as translation memory, terminology, and dictionaries
• Demonstrated ability to analyze and improve end‑to‑end business processes in a global, regulated environment
• Experience translating business and regulatory needs into structured, testable requirements in collaboration with cross‑functional teams
• Proven ability to work effectively with multiple stakeholders across business, regulatory, and technology functions
• Strong strategic thinking, problem‑solving, communication, and influencing skills
• Experience in global pharmaceutical or life sciences organizations, Neural Machine Translation solutions, project management practices, or additional languages will be considered a strong advantage

Offer:

• Direct employment with our Client, a leading global Big Pharma organization
• Stable, long‑term position within a highly regulated, international environment
• Hybrid working model (based in Poland)
• Opportunity to contribute to global, high‑impact initiatives supporting regulatory and business outcomes
• Collaboration with an international, experienced, and dynamic team
• Attractive benefits package, including private healthcare, sports card, and insurance