This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. The role...
You will play a pivotal role in ensuring the quality and compliance of Investigational Medicinal Products (IMPs) through your leadership and guidance of supplier management teams....
Write and review clinical (and nonclinical) documents for regulatory submissions in the EU and US, such as Module 2.5, 2.7, 2.4, 2.6, integrated summaries of efficacy/safety...
The role will provide leadership and strategic direction for assigned programs, ensuring the successful implementation of the quality strategy and/or quality plans to foster a...
Contribute to study protocol development including study concept, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate,...
Responsible for providing operational support for the planning, management, support and execution of regulatory activities for PTC drug products (clinical and commercial) within...
Designs and delivers innovative & collaborative medical affairs projects, has a significant role in developing and driving the Medical Affairs Plan, operates as a medical reviewer...