Assoc. Spclst. Regulatory Affairs

Merck•Rahway, NJ

3d•$71,900 - $113,200•Hybrid

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.

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