You will directly assist the Business Development Director in meeting the strategic, scientific, therapeutic, and commercial needs of MPP. The role contributes to shaping MPP business development strategy through the in...
The Global Regulatory CMC Lead develops and executes global regulatory CMC strategy for assigned Sobi assets in development, prepares CMC sections of IND/IMPD, MAA, NDA/BLA as well as assesses global filing strategy for post approval changes.
Own the end-to-end lifecycle of Pharmacovigilance Agreements (PVAs), including development, execution, maintenance, and termination where applicable, along with all associated deliverables. Contribute to strategy setting in collaboration with line
Responsible for leading and managing pharmaceutical development projects of drug entities within Development Bioanalytics (DevBA) from various customers and in different pre-clinical development phases; Accountable
Responsible for supporting the execution of the global medical plan for the assigned product in collaboration with the rest of the global medical team, as well as supporting the necessary cross-functional workstreams, while adhering to the
This role will be responsible for driving the management of our TTR amyloidosis franchise. This role will support and challenge country teams in tailoring the global strategy to the regional and local market specifics while maintaining global alignment;
Act as a subject matter expert (SME) for drug product (DP) manufacturing and validation activities; Lead and deliver MSAT projects focused on process optimization, robustness and cost improvements throughout the product lifecycle
Provide epidemiology and statistical analytical support for RWE studies; Contribute to the development of evidence generation plans and design of RWE studies for scientific and regulatory purposes; Advise study teams on research methodologies and