Focus állások, munkák törzskönyvezés kategóriában

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...

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

Perform critical scientific and statistical interpretation of clinical data, providing clear insights to support sound, evidence-based decision-making....

• Planning, writing, reviewing and submitting manuscripts on clinical drug trials in humans for peer-reviewed journals and abstracts for scientific conferences
• Data visualization of data from clinical drug trials
• Supporting preparation of posters and conference presentations

• 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.

• Support legal and compliance activities across ONPG
• Monitor adherence to internal Standard Operating Procedures (SOPs) and relevant pharmaceutical laws and regulations
• Maintain and continuously improve ONPG's contract database

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...