You are a hands-on Medical Expert responsible for executing clinical-scientific activities across the product lifecycle, focussed on the development of high-quality regulatory documentation (CTD) and support of global submissions and lifecycle management. * Ensure robust benefit–risk justification, regulatory alignment and high-quality documentation * Author, review and lead high-quality clinical and regulatory documents (CTD), including Clinical Overview & Clinical Summary, Clinical Expert Statements, Risk Management Plans (RMPs), SmPC, CCDS, PIL, PSURs / DSURs and other lifecycle documents * Ensure scientific consistency, quality across submissions and lifecycle documentation, including for complex products such as cell therapies / ATMPs
mehr