Alfasigma

The role involves developing and implementing regional regulatory strategies for low-complexity programs and single assets. It also provides regulatory support for clinical study start-up, execution, and the review of study documents to ensure compliance.

Define and execute the global strategy for the Gastroenterology and Hepatology therapeutic area, overseeing the clinical pipeline and portfolio investments. Lead the development of clinical programs from early stage through registration while collaborating with cross-functional R&D and commercial teams.

Lead the locoregional implementation of regulatory strategies for medium-complexity programs and manage submissions such as IND/CTA and NDA/MAA. Provide regulatory support to Clinical Operations and Development while coordinating with CROs and internal stakeholders.

Lead the authoring and review of complex clinical development documents, including protocols, CSRs, and regulatory submission modules. Manage document timelines, coordinate cross-functional reviews, and oversee vendor partnerships to ensure regulatory compliance.

Lead the authoring and review of complex clinical development documents, including protocols, CSRs, and regulatory submission modules. Manage vendor partnerships, coordinate cross-functional reviews, and ensure all documentation adheres to regulatory and company standards.