Regulatory Project Management Specialist -- US

Freyr Solutions is hiring a Regulatory Project Management Specialist to support global regulatory projects and submission activities. The role coordinates cross-functional teams, tracks regulatory milestones, and supports Global Regulatory Teams and Submission Working Groups.

Responsibilities:

• Support Submission Working Groups (SWG) by managing: SWG kick-off meetings
• Recurring SWG meetings
• Detailed regulatory submission timelines
• Risks, Actions, Issues, Decisions ( RAID ) logs
• Rapid Response Team ( RRT ) activities
• Lessons learned documentation
• Additional RPM support activities as required
• Support Global Regulatory Teams (GRT) by: Coordinating and supporting meetings
• Assisting with Regulatory Project Plans (RPP)
• Tracking GRT goals and deliverables
• Maintaining RAID logs
• Supporting additional RPM-related activities
• Independently manage and support non-SWG submission types
• Provide additional regulatory project support as required

Requirements:

• Bachelor's degree in Pharmaceutical Sciences, Medical Sciences, or a related scientific discipline , or equivalent experience
• 3–6 years of experience in the pharmaceutical or life sciences industry
• Minimum 2 years of project management experience
• Experience supporting regulatory submissions for major markets (US, EU, etc.)
• Experience supporting submissions such as IND, NDA, BLA, EU MAA, EU variations
• Familiarity with regulatory project planning and submission tracking
• Proficiency in Microsoft Office (Word, Excel, Outlook)
• Strong analytical and conceptual thinking
• Ability to work effectively in a fast-paced, deadline-driven environment
• Excellent communication and interpersonal skills
• Ability to multitask and prioritize competing assignments
• Strong collaboration and stakeholder management skills
• Fluency in English (written and verbal)
• preferably in Regulatory Affairs or Regulatory Operations
• Experience with Microsoft Project or equivalent tools (preferred)