Regulatory Project Manager

Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.

Why Freyr?

At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint, we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.

Join Our Team :

If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr. Together, we can shape the future of regulatory solutions.

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Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together!

Title : Regulatory Project Manager / Support Specialist

Location : Poland / UK

Experience : 4+ years in Regulatory Project Management.

• Independently manage submissions (and support 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 a timeline based on data availability and other critical path activities. Identify the critical path to submission. Maintain timeline during the 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 an agenda for kick-off prior to the meeting.
• overview, and other slides as needed).
• Send call for agenda prior to the meeting. Collect agenda topics from team members and prepare draft agenda for review with GRL / Reg Lead. Collect team member presentations for the meeting. Send the agenda to the team at least 1 day prior to the meeting.
• Keep the team on track and hold team members accountable to represent the function.
• Send meeting minutes to the 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 the risk log, and escalate to GRT for major risks.
• Create and maintain a submission timeline in Project Plan. Confirm RPP is updated as necessary. Identify and raise potential resource constraints to GRL / Reg Lead based on the timeline.
• Maintain SWG InterAct site.
• Create and distribute a dashboard for SWG.
• Perform scenario planning to identify possible outcomes based on identified risks.
• Attend functional sub-team meetings for modules 2-5 for tracking high-level submission timelines, risk identification, and overall alignment.
• Ensure any incomplete documents identified in the doc plan have a timeline that is being tracked in the overall submission timeline.
• Create a 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 sub-teams.
• Initiate and manage a rapid response team for agency questions, including the creation of a timeline. Ensure the 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 meetings, roundtable discussion, meeting preparation & team rehearsal, and post-meeting debriefs for HA Meetings
• Populates Content Plan Template with specifics for submission and metadata.
• Conduct Lessons Learned sessions and capture lessons in the lessons learned log.

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