Regulatory Submission Project Management Associate

We are hiring a Regulatory Submission Project Management Associate to support global regulatory operations by managing submission plans, coordinating deliverables, and ensuring timely completion of regulatory project milestones.If you have experience in regulatory submissions, project coordination, risk management, and cross-functional collaboration, this is a great opportunity to work in a highly regulated environment supporting worldwide product registrations and regulatory compliance activities.Key Responsibilities:• Partner with cross-functional product teams to develop and manage regulatory submission project plans• Coordinate submission activities to ensure timely delivery of project milestones and regulatory deliverables• Monitor project timelines and ensure responsible stakeholders are meeting commitments• Identify project risks, issues, and bottlenecks, and proactively implement mitigation plans• Provide visibility into critical path deliverables, escalating risks and delays to leadership when needed• Support preparation and submission of regulatory documentation for global product registrations• Ensure regulatory operations processes remain efficient, compliant, and inspection-ready• Facilitate communication across teams to resolve submission-related issues impacting timelines• Assist in maintaining compliance with domestic and international regulatory requirementsRequired Qualifications:• Bachelor’s degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or related field• Experience in regulatory submissions, regulatory operations, or submission project management• Working knowledge of global regulatory submission requirements and registration processes• Familiarity with FDA and international regulatory guidelines, standards, and policies• Strong project coordination, risk management, and stakeholder communication skills• Ability to manage multiple priorities in a fast-paced regulatory environment• Experience with regulatory systems/tools is preferredPreferred Knowledge & Skills:• Knowledge of regulatory submission/registration types and requirements• Understanding of global regulatory policies, compliance standards, and ethical guidelines• Experience working with cross-functional regulatory and product development teams• Strong organizational and problem-solving abilities