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.