Regulatory Affairs Associate

Regulatory to Operations (R2O) Associate (This is a contract position on the payroll of a 3rd party Vendor)

Job Description

The R2O Associate is accountable for processing regulatory documents required for product registrations globally. This role requires cross functional interaction with teams across multiple technical disciplines. Candidates should be results oriented and organized with a proven ability to work effectively within a centralized team environment as well as independently.

Responsibilities

• Coordinates global regulatory document preparation and delivery working closely with Country Regulatory Managers (CRMs), subject matter experts, manufacturing, and Global Regulatory Teams.
• Works closely with Country Regulatory Managers to understand the local requirements of the document requests.
• In some cases, this is done as part of a broader supply project team which will also require project management of requests, timelines, and prioritization to achieve project objectives.
• Utilizes the tracking tool for metrics.
• Executes the delivery of documents to the CRMs and archives a copy of the documentation for future reference and traceability.
• Monitors requests to ensure follow up and processing is completed in a timely fashion to meet business requirements.
• Ensures communication of project status to key stakeholders.
• Proactively reaches out to appropriate subject matter experts, global, regional, or country regulatory staff, or operations as needed to understand and implement specific requirements for document requests.
• Independently manages shifting priorities based on requests and document timelines.
• Participates in team meetings and effectively communicates with global regulatory and business staff.
• Champions continuous improvement within the team.
• Leads and/or participates in other projects or process improvement efforts as needed.