Salary
💰 $70,500 - $110,900 per year
About the role
- Maintain accountability for use of established planning and tracking practices and systems
- Participate in pilots for new tools and processes
- Collaborate with colleagues inside and outside of the department, as appropriate
- Participate in training courses to increase job role skills and regulatory knowledge
- Support in the creation of FDA cover letters and forms, creation of submission plans, assist in tracking deliverable timelines of components, and archiving in systems
- Provide regulatory submission/systems support
- Manage regulatory documents, assisting in tracking timelines/deliverables and/or components and promptly responding to updates
- Shared Services: (Regulatory Submission Specialist) Provide regulatory submission/systems support
- Assist in tracking deliverable timelines of components, and archiving in systems
Requirements
- High School Diploma or equivalent (no relative experience)
- Ability to communicate effectively, both verbally and written with others across cultures and organizational levels
- Demonstrates the ability to independently solve problems that arise within job responsibilities and expectations of this role
- Familiar with computer systems (MS Office necessary; Advanced Excel and Word skills preferred)
- Highly organized individual with keen attention to detail
- Demonstrated leadership, initiative, and ownership of deliverables
- US and Puerto Rico Residents Only (work authorization location restriction)
- No relocation
- VISA Sponsorship: No
- Valid Driving License: No