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 group in cross-functional planning to develop global regulatory submission and execution plans.
- Partner with document providers to ensure 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.
- Monitor 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.
