• Provide regulatory strategy advice and support the development and execution of regulatory strategies and plans • Ensure regulatory milestones are met to support approval strategies and overall business goals of the company • Plan, prepare and/or review submissions to regulatory authorities including FDA, EMA and other regulatory authorities to support the conduct of clinical trials and approval of marketing applications (e.g., IND, CTA, NDA/BLA, MAA) • Plan, author and/or review nonclinical and clinical study documents, including but not limited to: Clinical Study Protocols, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), nonclinical and clinical summaries and scientific publications • Plan, author and/or review chemistry, manufacturing and controls (CMC) documents, including but not limited to: CMC sections of regulatory applications as well as supporting records summarizing manufacturing process development and validation, analytical method development and validation, comparability study protocols and reports, stability study protocols and reports and justification of shelf-life/expiry dating • Ensure that regulatory documents are accurate, complete and verifiable and confirm compliance with regulatory requirements and conformance to the company quality standards • Track progress of regulatory deliverables against timelines, proactively communicate progress and issues to key stakeholders and support development of proactive mitigation plans for identified risks • Collaborate with vendors who support regulatory operations-related tasks • Assist with developing and maintaining regulatory document processing and regulatory submission publishing standards and procedures • Identify and communicate regulatory system enhancement needs or technical issues • Assist with regulatory inspection activities, as necessary.

Assist in assessing and monitoring the Information Security Program by conducting risk assessments, delivering compliance training, and identifying vendor-related risks while ensuring adherence to applicable privacy laws and security standards.

Title: Regulatory Specialist Location: Lake Zurich United States Job Description: time type Full time job requisition id R-01021946 Job Summary 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 Responsibilities 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/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%). Work from office 3 days per week and 2 days per week remote. 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. 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.

• Regulatory Compliance & Risk Management: Ensure compliance with U.S. and international import/export laws, including EAR, ITAR, OFAC, and other applicable regulations. • Monitor and interpret changes in trade regulations, tariffs, and trade programs (e.g., Section 301 & 232, USMCA, FTAs) and advise the business on necessary actions needed to ensure compliance. • Conduct internal audits, risk assessments, and compliance reviews; develop and track corrective actions. • Tariff Classification & Trade Controls: Oversee the Tariff Management program centered around Section 232 duties, Duty Drawback, and Free Trade Agreements. • Manage country of origin determination and valuation for import/export documentation. • Maintain accurate records to support preferential trade programs and duty drawback. • Operational Execution: Oversee day-to-day trade operations, including customs entries, export documentation, and licensing. • Partner with brokers, freight forwarders, and third-party logistics (3PL) providers to ensure timely and compliant movement of goods. • Collaborate with internal and external stakeholders to improve the Tariff Management program. • Training, Systems & Collaboration: Develop and deliver trade compliance training to relevant stakeholders across the organization. • Support the implementation and optimization of trade compliance modules within ERP or trade management systems. • Collaborate with cross-functional teams to ensure seamless integration of compliance into business practices.