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David Careers

Regulatory Project Management Specialist -- US

Posted 12 days ago

freyr solutionsSavannah (GA)
Regulatory Affairs SpecialistsPharmaceutical Preparation Manufacturing

SENIORITY

Senior

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About the role

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.
Job Title: Regulatory Project Management Specialist Location: Princeton NJ, Remote Employment Type: Full-Time/Permanent/Indefinite Role Overview The Regulatory Project Management Specialist 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.
Key Responsibilities:
  • Primary 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
  • Secondary Responsibilities Independently manage and support non-SWG submission types Provide additional regulatory project support as required
  • Stakeholder Interactions Global Regulatory Teams (GRT)
  • Submission Working Groups (SWG)
  • Cross-functional regulatory and project teams
  • External stakeholders, as applicable
  • Qualifications & Experience Education Bachelor’s degree in Pharmaceutical Sciences, Medical Sciences, or a related scientific discipline, or equivalent experience
  • Experience 3–6 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) Soft Skills 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)
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.

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