Assoc. Spclst. Regulatory Affairs
About The Position
The Associate Specialist of Regulatory Planning & Publishing works closely with various stakeholders of regulatory and safety submissions to assist in activities related to planning, execution, and management of delivery of high quality and timely regulatory submissions. This position is based at the Rahway, NJ Office, on a hybrid bases- 3 days in office; The incumbents will be required to commute to the Rahway, NJ Office, for these 3 days. The responsibilities of the incumbent may include the following: 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 Program: 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 Shared Services: (Regulatory Submission Specialist) Provide regulatory submission/systems support Manage regulatory documents, assisting in tracking timelines/deliverables and/or components and promptly responding to updates
Requirements
- High School Diploma or equivalent
- 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
Nice To Haves
- Demonstrated leadership
- Takes initiative
- Ownership of deliverables
Responsibilities
- 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
Benefits
- medical
- dental
- vision healthcare
- other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
