Regulatory Specialist

Fresenius Kabi USA•Lake Zurich, IL

1d•Hybrid

About The Position

The Regulatory Specialist reports to the Senior Manager, Regulatory Affairs. The Regulatory Specialist is responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers. Interacts with project teams and regulatory agencies in relation to submissions and other relevant topics. Trains new regulatory specialists. This position has no direct reports. Rate of Pay: $100,706.01 to $110,422.12 USD Annual

Requirements

Must have a Bachelor’s degree in Chemistry, Biochemistry, Biology, Biotechnology or related field and one (1) year of experience in pharmaceutical regulatory affairs or other scientific area supporting pharmaceutical regulatory affairs.
Must also possess the following: demonstrated expertise preparing and filing complete A/NDAs, Supplements, Amendments and Annual Reports to FDA; demonstrated expertise successfully completing supplements and/or amendments approved by the FDA; and, demonstrated expertise understanding CFR, FDA/ICH guidelines and cGMP’s, as they pertain to pharmaceuticals.

Responsibilities

Represent Regulatory Affairs Dept. on project teams and provide regulatory guidance to clearly and convincingly communicate complex issues as well as share expert knowledge of complex issues (15%).
Review technical documents for cGMP and regulatory compliance (10%).
Serve as an expert in technical areas in dealing with development and manufacturing organizations in U.S. and abroad (5%).
Prepare and file high-quality submissions to regulatory authorities including A/NDA’s, Supplements, Amendments, Annual Reports and DMF Updates (25%).
Communicate importance of quality assurance (5%).
Develop regulatory strategy for difficult issues which could significantly impact project timelines and costs (5%).
Provide regulatory decisions with regard to acceptability of submission documents and decisions (10%).
File all applications in accordance with predetermined timelines (15%).
Share with others best practices for planning, organization and time management (5%).
Function as a Special Projects Manager to support COO office on priorities, including project management, communications material development (5%).