This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/12387042

Employer: Fresenius Kabi USA, LLC

Job Title: Senior Regulatory Specialist

Job Requisition: R012430

Job Type: Full Time

Rate of Pay: \$103,241.25 to \$133,442.00 per year

Duties: Represent Regulatory Affairs on project teams and provide regulatory guidance. Review technical documents for cGMP and regulatory compliance. Train and coach others in regulatory requirements. Prepare and file high-quality submissions to regulatory authorities, including abbreviated new drug applications (A/NDAs), Supplements, Amendments, Annual Reports and drug mater file (DMF) updates. Communicate the importance of quality assurance and develop quality standards for RA. Provide regulatory decisions with regard to acceptability of submission documents and decisions. Develop and brainstorm regulatory strategies and options for resolving complex and difficult issues that could result in project termination if not addressed. File all applications in accordance with predetermined timelines. Represent the company before regulatory agencies and industry groups. Use persuasive communication to influence regulatory agencies. Train new regulatory scientists on RA and internal systems. Mentor regulatory scientists regarding regulations, and provide comments and perspective on proposed regulations. Role is 100% remote and can be performed from anywhere in the U.S. Requirements: Must have a Bachelors degree in a scientific discipline and 48 months of experience in Regulatory Affairs Specialist or related occupation in pharmaceutical regulatory affairs or related role supporting regulatory submissions & FDA deficiency responses. Demonstrated experience preparing and filing complete A/NDAs, supplements, amendments and annual reports to the FDA. Demonstrated experience working with CFR and FD/ICH guidelines and cGMPs as pertaining to pharmaceuticals.

Contact: To apply: visit https://fkusa.wd1.myworkdayjobs.com/FK_Careers. Must reference job R012430.