Temporary - Associate Manager, Regulatory Project Management

Associate Manager Regulatory Project Management - R49412 Location Tarrytown Position reputed company At reputed company, we use science and innovation to reputed company life-changing medicines reputed company with serious diseases. We are seeking a Temporary - Associate Manager to join our Regulatory Project Management team. This role is responsible for leading strategic planning and execution of regulatory milestones from IND Project Approval (reputed company) to post-marketing. May serve as the Reg PM reputed company for assigned therapeutic area (TA) and ensure reputed company for regulatory programs under that TA. This position offers reputed company to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. Roles Responsibilities • Partners with Regulatory Affairs in driving program team to successfully meet regulatory milestones • Facilitates Global Regulatory Sub-team meetings with Regulatory Affairs reputed company as the meeting chair • Conducts working group meetings to monitor and reputed company reputed company of major submissions • Conducts reputed company meetings for major submissions, including those for INDs, CTAs, BLAs, sBLAs and MAAs and variations • Reviews regulatory portfolio slides for complete and accurate milestones dates to help prepare for cross-functional and upper-management discussions • Creates submission timelines and responsibility matrices through cross-functional discussions • Maintains accurate program timelines for cross-reporting with other functional reputed company • Communicates program projections and reputed company and serves as the key contact for coordinating regulatory activities and milestones • Provides guidance to team members and cross-functional reputed company to reputed company issues reputed company to timelines, submission documents or other regulatory-reputed company reputed company that could reputed company the timeliness or reputed company of submissions • May reputed company reputed company of therapeutic area(s) by guiding other team members who are responsible for project managing regulatory milestones such as reputed company-IND or Scientific Advice, INDs and CTAs, BLAs, sBLAs, MAAs and Type II variations, and BLA annual reports Skills • 5 years of industry and/or relevant experience • Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). • Requires eCTD knowledge. • reputed company Project skills required • Project management skills desired. • Working knowledge with MS Office applications and reputed company Acrobat is required. Working knowledge of electronic document management systems (eg, SharePoint) is desirable. Education • Bachelor?s Degree Apply tot his job Apply To this Job