Regulatory Project Manager
ICON plc
Regulatory Project Manager
ICON plc
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Collaborate with regional and global cross-functional teams to plan, prepare, and deliver compliant regulatory submissions
- Create and manage project plans for regulatory projects using input from key stakeholders
- Lead and manage cross-functional submission teams from authoring to dispatch/project goal delivery
- Identify operational risks with projects/submissions, implement mitigation plans, and manage issues to closure
- Represent the Regulatory Project and Submission Management (RPSM) group in cross-functional planning to develop global regulatory submission and execution plans aligned with the client’s needs and regulatory team goals
- Partner with document providers to ensure the timely receipt of submission-ready documents for inclusion in global dossiers
- Communicate external agency submission standards and internal business submission processes to ensure compliance and efficiency in submission delivery
- Ensure the company remains aware of and responsive to external guidelines, regulations, market changes, and other factors related to global regulatory project and submission management
Requirements
- At least 5+ years of relevant experience in submissions, regulatory operations, or publishing
- Strong project management skills, with proficiency in Microsoft Project; experience with OnePager is preferred, and familiarity with Planisware is a plus
- A relevant educational background, such as a BA or higher in a life sciences discipline
- Experience in BLA submission
