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.
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