About Freyr
Freyr is a leading global Regulatory Solutions and Services company, supporting large, mid, and small-sized global Life Sciences companies. With a mission to accelerate compliance and enable businesses to bring their products to market faster, Freyr operates in a energetic, innovative, and collaborative environment. Our team of experts works on cutting-edge projects that drive meaningful impact across pharmaceuticals, biotechnology, cosmetics, food, and medical devices industries.
At Freyr, we believe in fostering talent and creating an inclusive work culture where employees are empowered to succeed. Join a company that values innovation, integrity, and the power of collaboration.
Role Overview
The Regulatory Project Manager (RPM) Support will assist in managing global regulatory projects, supporting submission activities, and ensuring effective coordination across cross-functional teams. This role will contribute to the planning, tracking,
and execution of regulatory submissions while supporting Global Regulatory Teams (GRT) and Submission Working Groups (SWG) to meet regulatory milestones and timelines.
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 Manag