Regulatory Affairs 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. Title : Regulatory Affairs Project Manager Location : Poland / Romania This role is open for candidates currently located in Poland and Romania only. Description : Primary 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 the 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 or any other mode as directed by Lead RPM/GRL. Record and track action items. Record decisions made and document in decision log for major decisions, if assigned. Record risks raised by team members in the risk log, if assigned. Escalate major risks to GRT. Create and maintain submission timeline in Project Plan. Update RPP, if assigned. 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 Kick-off 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, as asked by Lead RPM/GRL. Populates Content Plan template with specifics for submission and metadata. Conduct ‘Lessons Learned’ sessions and capture lessons in the lessons learned log, if assigned. #J-18808-Ljbffr Freyr Solutions