Regulatory Project Manager

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 dynamic, 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.

Job Title: Regulatory Project Manager (RPM) Support

Location: Remote

Employment Type: Full-Time / Permanent / Indefinite

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 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 Takeda 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.

Qualifications & Experience

Education

• Bachelor's degree in Pharmaceutical Sciences, Medical Sciences, or a related scientific discipline, or equivalent experience

Experience

• 4–6 years of experience in the pharmaceutical or life sciences industry
• Minimum 2 years of project management experience, preferably in Regulatory Affairs or Regulatory Operations
• Experience supporting regulatory submissions for major markets (US, EU, etc.)

Technical Skills

• Experience supporting submissions such as IND, NDA, BLA, EU MAA, EU variations
• Familiarity with regulatory project planning and submission tracking
• Experience with Microsoft Project or equivalent tools (preferred)
• Proficiency in Microsoft Office (Word, Excel, Outlook)

What We Offer:

Competitive salary and benefits package.

Flexible work environment (remote or hybrid options available).

Opportunity to work with a global team and contribute to impactful projects.

Continuous professional growth through training and development programs.

Inclusive, collaborative, and innovative work culture.

Why Join Freyr:

Be part of a global, fast-growing organization that operates in over 150 countries.

Opportunity to work on impactful projects in a dynamic and innovative environment.

Competitive salary and benefits package, including performance-based incentives.

Flexible work options to support work-life balance.

Continuous learning and professional development opportunities.

Collaborative and inclusive work culture that values diversity.