Regulatory Operations Specialist

Adelphi Group•New York, NY

34d•$45,000 - $160,000•Hybrid

About The Position

The Regulatory Operations Specialist position is an integral part of MRM Health and the Regulatory Operations capability. Regulatory Operations is accountable and responsible for the preparation, review, and submission of regulatory packages to Client Medical, Legal and Regulatory (MLR) groups. This position will support the Princeton pharmaceutical/health Client base. The Regulatory Operations Specialist will manage submission workflow and capacity for specific brands and work to achieve expert level status on Client regulatory submission, collaboration, and archive platforms/tools. This includes a supporting role in adhering to and maintaining processes and requirements for the capability.

Requirements

2 -4 years of experience in a relatable role preferred
Familiarity with agency submission process and MLR preferred
Strong interpersonal and problem-solving skills; be able to build strong relationships within the agency and client organizations, and must be able to participate in client and internal agency meetings with senior personnel
Ability to manage multiple projects as one cohesive program
Capacity for risk identification and management
Strong sense of ownership of process and results
Strong writing and verbal skills
High-level of organization and detail with an ability to influence others in these areas
Ability to find creative solutions to complex problems and multi-task
Must be comfortable working in an environment that utilizes electronic docbases, databases, and computer systems (Microsoft Office, Veeva Vault, Zinc, and web based applications)
Experience and competence in MS Office

Nice To Haves

Workload management and people supervisory experience a plus

Responsibilities

Serve as day-to-day submissions lead; manage and filter workload to team members
Demonstrate general knowledge of Regulatory Affairs and guidelines that govern advertising and promotional material according to FDA
Work cross functionally with Project Management to ensure submission timelines are met and all material is gathered for accurate and timely submissions
Learn client-based submission systems and be able to navigate for efficient use, including the tagging and linking of references based on annotations provided by Copy team
Maintain reference library and asset library for internal cross-functional use
Execute submissions in the following manner: Initiate the submission process, Track the project from kickoff through to final submission Client MLR approval, Organize submission materials in accordance with the Client dictated requirements, Ensure integrity of submission materials to ensure adherence with Client MLR requirements, Submit materials via Client MLR submission platform/tool, Provide status updates on submission progresses, Support team with prepping and sending final samples, and 2253 materials when needed
Record keeping and knowledge base: Document and maintain project tracker, Document and maintain current Client requirements for MLR submission, Maintain knowledge of the Client MLR schedule, Utilize and maintain regulatory document control and appropriate distribution of regulatory documents