Senior Program Manager Lead
CurrentResponsibilities:• Managing all on going project timelines and deliverables.• Developing department budgetary outlines.• Managing Senior Publisher projects.• Company representative at trade shows and conferences. • Coordinating with clients for application maintenance and updates.• Guiding clients through regulatory application processes for FDA/EMA/HC.• Preparing eCTD sequences for submission to FDA/EMA/HC.• Assembling new applications for submission to FDA/EMA/HC.• Consulting with clients on new IND and DMF applications. • Authoring SPLs for prescription and OTC drug labels.• Recruiting all new regulatory hires.• Training all new regulatory hires.