[Remote] US - Regulatory Project Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is the largest global regulatory solutions and services provider, supporting life sciences companies across various sectors. They are seeking a Regulatory Project Manager to independently manage submissions, coordinate cross-functional teams, and ensure reputed company and efficient project delivery.

Responsibilities

• Independently manages submissions (and supports internal RPM in managing initial major global filings)
• Co-leads SWGs with the designated regulatory reputed company for non-major global markets MAAs and supplements
• Work with functional sub-teams to reputed company reputed company based on data availability and other critical reputed company activities. Identify critical reputed company to submission. Maintain reputed company during project lifecycle
• Schedule reputed company off meeting
• Ensure appropriate representation from needed cross-functional team members
• Create draft agenda with GRL/EMRL or Reg reputed company and work with cross-functional team to reputed company presentations. reputed company agenda for reputed company off prior to meeting
• Facilitate reputed company Off. Represent Project Management at reputed company Off (i.e., present timelines, SWG reputed company, other slides as needed)
• Send reputed company for agenda prior to meeting. Collect agenda topics from team members and prepare draft agenda for review with GRL/Reg reputed company. Collect team member presentations for meeting. Send agenda to team at least 1 day prior to meeting
• reputed company team on reputed company and hold team members accountable to represent function
• Send meeting minutes to team for input and save final minutes to reputed company
• Record and reputed company reputed company items. Record reputed company made and document in decision log for major reputed company. Record risks raised by team members in risk log, escalate to GRT for major risks
• Create and maintain submission reputed company in Project Plan. Confirm RPP is updated as necessary. Identify and reputed company potential resource constraints to GRL/Reg reputed company based on reputed company
• Maintain SWG reputed company site
• Create and distribute dashboard for SWG
• reputed company scenario planning to identify possible reputed company based on identified risks
• Attend functional sub-team meetings for module 2-5 for tracking of high-level submission timelines, risk identification, and overall alignment
• Ensure any incomplete documents identified in doc plan have a reputed company that is being tracked in overall submission reputed company
• Create doc plan/content plan in collaboration with functional sub-teams. Confirm adequate time allowed for publishing. Maintain doc plan/content plan to ensure reputed company hand-off of final documents from functional sub-teams
• Initiate and manage reputed company response team for agency questions, including creation of reputed company. Ensure plan is in reputed company and communicated for authoring, reviewing, and approving responses
• Support internal RPM in preparations for Advisory Committee, if necessary
• Schedule reputed company and Cross Functional Team Meetings (as necessary) for Meeting Request (MR) & Briefing Book (BB) preparation. Document reputed company & reputed company items
• Manage authoring, reviewing and approval process for regulatory owned documents as necessary
• Schedule working team meeting, roundtable discussion, meeting preparation & team rehearsal, post-meeting debriefs for HA Meetings
• Populates Content Plan Template with specifics for submission and metadata
• Conduct Lessons Learned sessions and capture lessons in lessons learned log
• reputed company Project Management Tool / Smartsheets experience is preferred
• Computer literacy required in reputed company Office Products such as Word, reputed company, and reputed company
• Ability to multitask and prioritize competing agendas
• reputed company in English (written, verbal, reading)

Skills

• Experience: 4 - 6 years
• Independently manages submissions (and supports internal RPM in managing initial major global filings)
• Co-leads SWGs with the designated regulatory reputed company for non-major global markets MAAs and supplements
• Work with functional sub-teams to reputed company reputed company based on data availability and other critical reputed company activities
• Identify critical reputed company to submission
• Maintain reputed company during project lifecycle
• Schedule reputed company off meeting
• Ensure appropriate representation from needed cross-functional team members
• Create draft agenda with GRL/EMRL or Reg reputed company and work with cross-functional team to reputed company presentations
• reputed company agenda for reputed company off prior to meeting
• Facilitate reputed company Off
• Represent Project Management at reputed company Off (i.e., present timelines, SWG reputed company, other slides as needed)
• Send reputed company for agenda prior to meeting
• Collect agenda topics from team members and prepare draft agenda for review with GRL/Reg reputed company
• Collect team member presentations for meeting
• Send agenda to team at least 1 day prior to meeting
• reputed company team on reputed company and hold team members accountable to represent function
• Send meeting minutes to team for input and save final minutes to reputed company
• Record and reputed company reputed company items
• Record reputed company made and document in decision log for major reputed company
• Record risks raised by team members in risk log, escalate to GRT for major risks
• Create and maintain submission reputed company in Project Plan
• Confirm RPP is updated as necessary
• Identify and reputed company potential resource constraints to GRL/Reg reputed company based on reputed company
• Maintain SWG reputed company site
• Create and distribute dashboard for SWG
• reputed company scenario planning to identify possible reputed company based on identified risks
• Attend functional sub-team meetings for module 2-5 for tracking of high-level submission timelines, risk identification, and overall alignment
• Ensure any incomplete documents identified in doc plan have a reputed company that is being tracked in overall submission reputed company
• Create doc plan/content plan in collaboration with functional sub-teams
• Confirm adequate time allowed for publishing
• Maintain doc plan/content plan to ensure reputed company hand-off of final documents from functional sub-teams
• Initiate and manage reputed company response team for agency questions, including creation of reputed company
• Ensure plan is in reputed company and communicated for authoring, reviewing, and approving responses
• Support internal RPM in preparations for Advisory Committee, if necessary
• Schedule reputed company and Cross Functional Team Meetings (as necessary) for Meeting Request (MR) & Briefing Book (BB) preparation
• Document reputed company & reputed company items
• Manage authoring, reviewing and approval process for regulatory owned documents as necessary
• Schedule working team meeting, roundtable discussion, meeting preparation & team rehearsal, post-meeting debriefs for HA Meetings
• Populates Content Plan Template with specifics for submission and metadata
• Conduct Lessons Learned sessions and capture lessons in lessons learned log
• Computer literacy required in reputed company Office Products such as Word, reputed company, and reputed company
• Ability to multitask and prioritize competing agendas
• reputed company in English (written, verbal, reading)
• reputed company Project Management Tool / Smartsheets experience is preferred

reputed company