Regulatory Affairs jobs in Germany

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions.

The Director, Project Management is responsible for providing strategic and operational leadership across complex oncology projects. This role ensures end-to-end delivery excellence, timeline ownership, risk mitigation, and high-quality execution across multiple countries.

As part of our SRS / FSP team, you will be dedicated to one sponsor, a global pharmaceutical company with a strong commitment to evidence generation across the product lifecycle.

Please keep in mind that this is a part-time freelance opportunity at approximately 0.3 FTE.

• Lead annual and monthly operational planning, ensuring alignment with sponsor priorities, resourcing, and budget expectations
• Provide strategic oversight of feasibility, site contracting, regulatory submissions, and amendments across multiple countries
• Drive cross-country harmonisation of study documents, processes, and operational standards
• Ensure robust TMF oversight and quality governance, maintaining inspection readiness at all times

Prepare, lead, and follow up on governance and steering committee meetings, ensuring clear decision‑making and action tracking

• University degree in Life Sciences, Pharmacy, Medicine, or a related field; Master’s degree preferred
• Extensive experience (10+ years) in clinical project management within a CRO or pharmaceutical environment
• Demonstrated leadership experience in Oncology clinical trials, with a strong focus on breast cancer studies
• Proven expertise in Real World Evidence (RWE) and Non‑Interventional Studies
• Strong knowledge of ICH‑GCP, EU regulatory requirements, and observational study regulations
• Excellent stakeholder management, communication, and leadership skills across cross‑functional and cross‑country teams

We provide a competitive compensation package, comprehensive benefits, and the opportunity for continued personal and professional growth in a strategic leadership role. You will work in a highly collaborative environment with exposure to innovative oncology programs and senior decision‑makers, while having a direct impact on study delivery and patient outcomes.

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full‑service, global Contract Research Organization (CRO), we build solution‑driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions at every level. By aligning on these values, we foster a culture of collaboration, innovation, and excellence. Together, we make a difference.