Job Summary Oversees the preparation and submission of regulatory documents, provides strategic direction for product registration, liaises with regulatory agencies, and advises project teams on compliance matters to ensure the approval and continued market presence of life sciences and agricultural products. Responsibilities Rate of Pay: $100,706.01 to $110,422.12 per Year Duties: 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/NDAs, 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%). 1 day per week in the office, remote 4 days per week. Requirements: Must have a Bachelors degree in Chemistry, Biochemistry, Biology, Biotechnology or related field and one (1) year of experience in pharmaceutical regulatory affairs or other scientific area. Special Skills, Other Special Skills or Requirements: 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 cGMPs, as they pertain to pharmaceuticals. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status. Fresenius Kabi (www.CaringForLife.us) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the companys global headquarters is in Bad Homburg, Germany. Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr Fresenius Kabi is aware that scammers may attempt to impersonate our recruiters. While we have limited ability to stop these illegitimate efforts, there are some things you can do to protect yourself and not waste time communicating with an imposter. Check the email address messages from our recruiters will always come from a company account with the Fresenius-kabi.com domain. We have seen imposters send emails using Fresenius-kaabi.com which of course includes an extra a in Kabi. Check our website to see if the position you were contacted about is actually posted. Be wary if someone asks you for personal information. We do not need your drivers license, social security number, or bank account information before we have made you a conditional offer of employment. Refuse to pay any upfront fees. Fresenius Kabi never charges you a fee to apply for a job at Fresenius Kabi. We will not send you an invoice for equipment (such as a laptop) that we promise to order and reimburse you for once you start working. If you have any questions at any stage of the process, contact us at Careers@fresenius-kabi.com. Do not use any contact information in an unsolicited email. We look forward to talking to you about joining our team.
