Regulatory specialist
Integrated Resources
Regulatory Specialist
IRI believes in commitment, integrity, and strategic workforce solutions.
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled, and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.
Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients' success.
Job Description
The Regulatory Specialist will be responsible for activities to ensure product registration information is accurate and current.
The person will support the compilation, tracking, and processing of regulatory documentation (e.g., affiliate requests, technical documentation, regulatory submissions).
This individual will also be responsible to monitor and track the activities and expenses performed by vendors for Regulatory Operations ensuring a high-level of quality deliverables.
A minimum of 2 years of relevant professional experience in a business environment is required.
Experience in compiling regulatory documentation and/or obtaining CFG (Certificates to Foreign Governments) from FDA or CFS (Certificates of Free Sale) in Europe is preferred.
Must have ability to work both within a team and independently in a fast paced, changing environment.
Must possess clear verbal and written communication skills, attention to detail, strong organizational and project management skills and ability to problem solve, recognize and find solutions for gaps in processes.
Must be proficient with MS Office applications.
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