Programmer manager állások Németországban (törzskönyvezés)

Providing strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and managing lifecycle regulatory activities in alignment with the Therapeutic Area Lead under the direction of the Senior...

• Cover the PRRC role when requested from the needs of the company (e.g. during the absence of the current PRRC)
• Develop and execute regulatory strategies for products and services
• Provide regulatory expertise for complex or unique issues and challenges regarding registration and compliance activities.

Scientific oversight and coordination of preclinical and toxicology studies conducted in collaboration with CROs, academic partners, and scientific institutions - covering both GLP-regulated and exploratory/non‑GLP research...

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

• Confirms, certifies, and releases batches of products manufactured, ensuring all manufacturing steps have been performed in compliance with GMP, the marketing authorization of the relevant product, defined procedures, and current regulations.
• Confirms batches of products intended for clinical trials.