๐๐ถ๐ฟ๐ถ๐ป๐ด: Project Manager I (Regulatory / Medical Device)
๐๐ผ๐ฐ๐ฎ๐๐ถ๐ผ๐ป: Des Plaines, IL
Job Summary
The Submission Project Management Associate is a key member of the Regulatory Operations team, responsible for supporting the planning, coordination, and execution of regulatory submission projects. This role ensures timely delivery of submission deliverables by collaborating with cross-functional teams, monitoring project progress, and proactively managing risks and issues. The position requires a strong understanding of regulatory processes, project management principles, and compliance standards.
Key Responsibilities
- Manage and support regulatory submission projects across the full project lifecycle, ensuring alignment with timelines, scope, and quality standards.
- Collaborate with product teams, stakeholders, and business units to define project scope, objectives, and deliverables.
- Develop, track, and maintain detailed project plans, schedules, and documentation.
- Monitor project progress and ensure deliverables are completed on time and meet regulatory requirements.
- Identify project risks and issues; develop and execute mitigation plans to ensure continuity of critical path activities.
- Provide regular status updates, tracking reports, and presentations to stakeholders and management.
- Facilitate communication and coordination among cross-functional teams to ensure project alignment.
- Assist in the preparation, compilation, and submission of regulatory documentation for global product registrations.
- Ensure compliance with regulatory standards, guidelines, and internal processes.
- Escalate critical risks, delays, or issues to senior management as appropriate.
- Provide guidance and support to team members to ensure project success.
Qualifications & Experience
- Bachelorโs degree in Life Sciences, Pharmacy, Regulatory Affairs, Business Administration, or related field.
- 1โ6 years of experience in project management, regulatory operations, or related domain.
- Understanding of regulatory submission processes and global regulatory requirements.
- Experience working with cross-functional teams in a matrix environment.
- Strong organizational, analytical, and problem-solving skills.
- Excellent communication, presentation, and stakeholder management abilities.
- Ability to manage multiple projects and priorities simultaneously.
Regulatory Knowledge & Skills
- Knowledge of regulatory guidelines, policies, standards, and submission requirements.
- Familiarity with domestic and international regulatory frameworks.
- Understanding of regulatory documentation, submission types, and registration processes.
- Awareness of ethical standards in regulatory affairs and clinical research.
Key Competencies
- Project Planning & Execution
- Risk Management
- Stakeholder Communication
- Attention to Detail
- Problem Solving
- Time Management
- Regulatory Compliance Awarenes
