▷ [Aplica ya] Regulatory Affairs Project Manager...

About the Company

Freyr Life Sciences; The Largest Global Regulatory Solutions & Services Provider, Supporting, Large, Mid & Small global Life Sciences companies, (Pharmaceutical | Generics | Medical Device | Consumer Healthcare | Cosmetics | Biotechnology | Chemicals | Biosimilar | Biocides) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related function.

Regulatory Consulting & Strategy, Regulatory Operations & Affairs, Regulatory Software Solutions, Regulatory Information & Intelligence, Global Regulatory Responsibility Services, Regulatory Publishing & Submission, Regulatory Medical Writing, IDMP, Medical Devices Regulatory Services, Regulatory Artwork & Labeling, CMC, Medical Devices, Pharmaceutical, Biotechnology, Biosimilar, Cosmetics, Consumer Healthcare, OTC, Regulatory Intelligence, food supplements, Global Regulatory Affairs, Labeling, Artwork, chemicals, eCTD, and Regulatory software solutions

Job title : Regulatory Project manager - US Submissions experience Mandatory

Job Type : Permanent / Full-time / Indefinite

Work Location : Bogota, Colombia (Remote)

Description :

Experience : 8 - 15 years

Responsibilities

• Independently 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 supplements
• Work 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 lifecycle.
• Schedule kick off meeting.
• Ensure appropriate representation from needed cross-functional team members.
• Create draft agenda with GRL / EMRL or Reg Lead and work with cross-functional team to gather presentations. Provide agenda for kick off prior to meeting.
• Facilitate 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 meeting.
• Keep team on track and hold team members accountable to represent function.
• Send meeting minutes to team for input and save final minutes to InterACT
• Record 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 risks.
• Create 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 timeline.
• Maintain SWG InterACT site.
• Create and distribute dashboard for SWG.
• Perform scenario planning to identify possible outcomes 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 timeline that is being tracked in overall submission timeline.
• Create 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-teams.
• Initiate and manage rapid response team for agency questions, including creation of timeline. Ensure plan is in place and communicated for authoring, reviewing, and approving responses.
• Support internal RPM in preparations for Advisory Committee, if necessary
• Schedule Kickoff and Cross Functional Team Meetings (as necessary) for Meeting Request (MR) & Briefing Book (BB) preparation. Document decisions & action 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.
• Microsoft Project Management Tool / Smartsheets experience is preferred
• Computer literacy required in Microsoft Office Products such as Word, Excel, and Outlook
• Ability to multitask and prioritize competing agendas
• Fluency in English (written, verbal, reading).

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