Regulatory Affairs Specialist

Axogen•Tampa, FL

About The Position

The Regulatory Affairs Specialist will assist the Regulatory Affairs Leads and broader organization in navigating regulatory approval procedures and management of regulated information as part of the Regulatory Affairs Strategic and Centralized Services team. The specialist is a crucial link between the Regulatory Affairs Centralized Services team, Regulatory Affairs Product Leads, Axogen Regulatory data and information management systems, and legal and business functions across the organization.

Requirements

A degree or certification-level qualification in a relevant life sciences discipline (i.e. an Associate Degree or 1-3 years’ work experience) in healthcare, research, or another science-related field
Must be detailed oriented and highly organized with the ability to prioritize and organize projects to meet deadlines, while being flexible to unexpected priority requests
Must have strong verbal, written, and interpersonal communication skills
Excellent judgment, problem-solving abilities, and the ability to work in a team environment
Experience with a multi-location office setting with core contributors to the work product in remote or virtual settings
Must respect the confidential nature of the work and information held in Regulatory Affairs
Proactive and action-oriented, able to accept and act upon directions within the Regulatory Affairs matrix
Must have the ability and desire to learn new software and procedures quickly
Strong technological aptitude

Nice To Haves

Medical or Industry terminology knowledge is a benefit but not required

Responsibilities

Assist with development strategy and preparation for team/project meetings
Assist with the development and/or review of regulatory documents to ensure that all submissions are of high quality:
Coordinate and organize regulatory information, data, documents, and other information in support of regulatory filings or procedures
Interface with functional areas (Development, Operations, QA, QC, Engineering) to obtain information identified by the Regulatory Affairs Lead as required for regulatory submissions
Assist Regulatory Affairs Leads with preparing, coordinating, assembling, and lifecycle management of regulatory dossiers for investigational product applications, annual reports, and information amendments.
Assists Regulatory Affairs Leads with preparing, coordinating, assembling, and lifecycle management of regulatory dossiers for Regulatory Authority peri-approval procedures, Marketing Authorization, or Clearance procedures
Assists Regulatory Affairs Leads with preparing, coordinating, and assembling Agency Information Requests/Query responses
Compiles information and maintains regulatory documentation databases and information management systems in compliance with regulatory requirements
Management of Regulatory Authority Communication Logs, Compliance activity logs, Product Portfolio and Asset Information,
Scans, files, and archives documents
Ensures all regulatory documentation is compliant with Standard Operating Procedures (SOP’s) for format, content, and storage.
Provides administrative support for the activities conducted by the Regulatory Affairs Department including:
Preparing, coordinating, and organizing data and other information in support of regulatory business reporting and information management
Summarizing correspondence and/or providing meeting minutes or dashboard updates to/for related activities
Scheduling meetings, expense tracking and submission as well as travel planning, purchase order and vendor creation.
Provide summaries of complex communication and follow-up to ensure proper and timely action is taken in the Regulatory Affairs Centralized Services function
Supports the supervisor’s role