[Remote] US - Regulatory Project Manager

Note: The job is a remote job and is open to candidates in USA. Freyr Solutions is the largest global regulatory solutions and services provider supporting life sciences companies. The Regulatory Project Manager will independently manage submissions and coordinate cross-functional teams to ensure timely and successful regulatory filings.ResponsibilitiesIndependently manages submissions (and supports internal RPM in managing initial major global filings)Co-leads SWGs with the designated regulatory lead for non-major global markets MAAs and supplementsWork with functional sub-teams to develop timeline based on data availability and other critical path activities. Identify critical path to submission. Maintain timeline during project lifecycleSchedule kick off meetingEnsure appropriate representation from needed cross-functional team membersCreate draft agenda with GRL/EMRL or Reg Lead and work with cross-functional team to gather presentations. Provide agenda for kick off prior to meetingFacilitate Kick Off. Represent Project Management at Kick Off (i.e., present timelines, SWG overview, other slides as needed)Send call for agenda prior to meeting. Collect agenda topics from team members and prepare draft agenda for review with GRL/Reg Lead. Collect team member presentations for meeting. Send agenda to team at least 1 day prior to meetingKeep team on track and hold team members accountable to represent functionSend meeting minutes to team for input and save final minutes to InterACTRecord and track action items. Record decisions made and document in decision log for major decisions. Record risks raised by team members in risk log, escalate to GRT for major risksCreate and maintain submission timeline in Project Plan. Confirm RPP is updated as necessary. Identify and raise potential resource constraints to GRL/Reg Lead based on timelineMaintain SWG InterACT siteCreate and distribute dashboard for SWGPerform scenario planning to identify possible outcomes based on identified risksAttend functional sub-team meetings for module 2-5 for tracking of high-level submission timelines, risk identification, and overall alignmentEnsure any incomplete documents identified in doc plan have a timeline that is being tracked in overall submission timelineCreate doc plan/content plan in collaboration with functional sub-teams. Confirm adequate time allowed for publishing. Maintain doc plan/content plan to ensure timely hand-off of final documents from functional sub-teamsInitiate and manage rapid response team for agency questions, including creation of timeline. Ensure plan is in place and communicated for authoring, reviewing, and approving responsesSupport internal RPM in preparations for Advisory Committee, if necessarySchedule Kickoff and Cross Functional Team Meetings (as necessary) for Meeting Request (MR) & Briefing Book (BB) preparation. Document decisions & action itemsManage authoring, reviewing and approval process for regulatory owned documents as necessarySchedule working team meeting, roundtable discussion, meeting preparation & team rehearsal, post-meeting debriefs for HA MeetingsPopulates Content Plan Template with specifics for submission and metadataConduct Lessons Learned sessions and capture lessons in lessons learned logSkillsExperience: 4 - 6 yearsIndependently manages submissions (and supports internal RPM in managing initial major global filings)Co-leads SWGs with the designated regulatory lead for non-major global markets MAAs and supplementsWork with functional sub-teams to develop timeline based on data availability and other critical path activitiesIdentify critical path to submissionMaintain timeline during project lifecycleSchedule kick off meetingEnsure appropriate representation from needed cross-functional team membersCreate draft agenda with GRL/EMRL or Reg Lead and work with cross-functional team to gather presentationsProvide agenda for kick off prior to meetingFacilitate Kick OffRepresent Project Management at Kick Off (i.e., present timelines, SWG overview, other slides as needed)Send call for agenda prior to meetingCollect agenda topics from team members and prepare draft agenda for review with GRL/Reg LeadCollect team member presentations for meetingSend agenda to team at least 1 day prior to meetingKeep team on track and hold team members accountable to represent functionSend meeting minutes to team for input and save final minutes to InterACTRecord and track action itemsRecord decisions made and document in decision log for major decisionsRecord risks raised by team members in risk log, escalate to GRT for major risksCreate and maintain submission timeline in Project PlanConfirm RPP is updated as necessaryIdentify and raise potential resource constraints to GRL/Reg Lead based on timelineMaintain SWG InterACT siteCreate and distribute dashboard for SWGPerform scenario planning to identify possible outcomes based on identified risksAttend functional sub-team meetings for module 2-5 for tracking of high-level submission timelines, risk identification, and overall alignmentEnsure any incomplete documents identified in doc plan have a timeline that is being tracked in overall submission timelineCreate doc plan/content plan in collaboration with functional sub-teamsConfirm adequate time allowed for publishingMaintain doc plan/content plan to ensure timely hand-off of final documents from functional sub-teamsInitiate and manage rapid response team for agency questions, including creation of timelineEnsure plan is in place and communicated for authoring, reviewing, and approving responsesSupport internal RPM in preparations for Advisory Committee, if necessarySchedule Kickoff and Cross Functional Team Meetings (as necessary) for Meeting Request (MR) & Briefing Book (BB) preparationDocument decisions & action itemsManage authoring, reviewing and approval process for regulatory owned documents as necessarySchedule working team meeting, roundtable discussion, meeting preparation & team rehearsal, post-meeting debriefs for HA MeetingsPopulates Content Plan Template with specifics for submission and metadataConduct Lessons Learned sessions and capture lessons in lessons learned logComputer literacy required in Microsoft Office Products such as Word, Excel, and OutlookAbility to multitask and prioritize competing agendasFluency in English (written, verbal, reading)Microsoft Project Management Tool / Smartsheets experience is preferredCompany OverviewFreyr is a Global, Regulatory-focused solutions and services company for Life Sciences Companies supporting, Large, Medium, and Small firms. It was founded in 2011, and is headquartered in Princeton, New Jersey, USA, with a workforce of 1001-5000 employees. Its website is http://www.freyrsolutions.com/.