Associate Specialist - Regulatory Affairs (Hybrid)

MSD•Philadelphia, PA

2d•$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 Philadelphia, PA, WeWork Office, on a hybrid bases- 3 days in office; The incumbents will be required to commute to the Philadelphia, PA, WeWork 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.
Accountability
Communication
Computer Literacy
Customer Satisfaction
Deliverables Management
Document Control Systems
Independent Thinking
Microsoft Word
Taking Ownership
Working Independently

Nice To Haves

Demonstrated leadership.
Takes initiative.
Ownership of deliverables.
Project Management

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.