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Develop and execute RH clinical plans supporting new product introduction, lifecycle management, and regulatory submissions; Translate product requirements and regulatory needs into practical study designs, including sample strategy, specimen sourcing,
In this role, you will provide expert support for clinical trial quality, ensure compliance with ICH-GCP and global regulatory expectations, and act as a key partner to internal teams and CROs. You will be responsible for quality oversight, process
You will provide communication expertise and lead a strategy-driven approach to authoring of key clinical and regulatory documents and regulatory submissions, to ensure clarity, credibility and consistency of clinical information throughout submission
This key role will be responsible for ensuring the development and delivery of science-based, solution-oriented, and internally aligned regulatory CMC strategies for the program(s) under his/her accountability. Create high quality compliant CMC
Lead comprehensive post-marketing surveillance activities including proactive monitoring, adverse event trend analysis, signal detection, and signal management for assigned veterinary products, ensuring compliance with global regulatory standards.