Main purpose of role:
Provide regulatory support and expertise for the Row-America portfolio.
Work cross-functionally and in collaboration with key stakeholders/customers both internal (e.g. commercial, technical, quality, medical, supply chain etc.) and external (e.g. local regulatory partners, local distributors and MA holders, regulatory agencies, CMOs).
Act as contact point/knowledge base for scientific & technical aspects of module 1 (administrative including labelling) and module 3 (CMC - chemistry, manufacture and control) documents and associated regulatory activities.
Management of allocated product portfolio.