About FreyrFreyr 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.Role OverviewThe Regulatory Project Manager (RPM) Support will assist porting 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 ResponsibilitiesPrimary ResponsibilitiesSupport Submission Working Groups (SWG) by managing: SWG kick-off meetingsRecurring SWG meetingsDetailed regulatory submission timelinesRisks, Actions, Issues, Decisions ( RAID ) logsRapid Response Team ( RRT ) activitiesLessons learned documentationAdditional RPM support activities as requiredSupport Global Regulatory Teams (GRT) by: Coordinating and supporting meetingsAssisting with Regulatory Project Plans (RPP)Tracking GRT goals and deliverablesMaintaining RAID logsSupporting additional RPM-related activitiesSecondary ResponsibilitiesIndependently manage and support non-SWG submission typesProvide additional regulatory project support as requiredStakeholder InteractionsGlobal Regulatory Teams (GRT)Submission Working Groups (SWG)Cross-functional regulatory and project teamsExternal stakeholders, as applicableQualifications & ExperienceEducationBachelor’s degree in Pharmaceutical Sciences, Medical Sciences, or a related scientific discipline, or equivalent experienceExperience4–6 years of experience in the pharmaceutical or life sciences industryMinimum 2 years of project management experience, preferably in Regulatory Affairs or Regulatory OperationsExperience supporting regulatory submissions for major markets (US, EU, etc.)Technical SkillsExperience supporting submissions such as IND, NDA, BLA, EU MAA, EU variationsFamiliarity with regulatory project planning and submission trackingExperience with Microsoft Project or equivalent tools (preferred)Proficiency in Microsoft Office (Word, Excel, Outlook)Soft SkillsStrong analytical and conceptual thinkingAbility to work effectively in a fast-paced, deadline-driven environmentExcellent communication and interpersonal skillsAbility to multitask and prioritize competing assignmentsStrong collaboration and stakeholder management skillsFluency 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.
10 days ago