Fresenius Kabi USA

Compensation

Full Description

Job Summary The Senior Manager, Regulatory Affairs delivers Regulatory Affairs and compliance guidance and strategic input as a subject matter expert in Biosimilar Development and Life Cycle Management to find smart solutions for optimized submission, submission rollout, and maintenance. Autonomously drive the regulatory strategy. Manage cross functional activities for dossier preparation and submission packages through processes, systems, and tools. Plan and manage submission rollout and Maintenance/Life-cycle management. Manage and lead health authority interactions and ensure implementation of feedback in the projects. Influence and shape the regulatory landscape and future regulations. This role will lead specialized and business multiyear critical regional and global projects with key customers. *This position requires working onsite 3 days per week at our U.S. headquarters in Lake Zurich, IL. *This position does not offer visa sponsorship either now or in the future. • Salary Range: $165,000-175,000 • Position is eligible to participate in an annual bonus plan with a target of 14% of the base salary. • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. • Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Responsibilities Lead the Regulatory Sub-team and as needed, Regulatory Strategic Submission Teams. Provide global regulatory leadership regarding biosimilar development and management of submission related documents, and regulatory data for Biosimilars. Lead preparation, rehearsal, and manage meetings with Health Authorities. As the Regulatory representative in the Biosimilar Development Team and/or other Strategic Teams, develop, supervise, and manage the submission strategy of Biosimilar dossier that best serves the biosimilars business needs, whilst ensuring the work is done in compliance with Fresenius Kabi regulatory procedures and systems. Ensure the regulatory strategy is endorsed by the Development Team or other Decision Committee, as appropriate. In alignment with the Development team, establish necessary regulatory story line for regulatory interactions (briefing book consultations and submission dossier). In close collaboration with Regulatory Operations, contribute to and support strategies to implement technologies supporting all current and future authorities’ requirements and ensure consistency of standards in systems and processes across relevant Biosimilar functions. Provide global guidance and support to Market units in their interactions with local health authorities (life cycle management) including mapping of regulatory constraints. Contribute to the assessment related to wave 2 submission prioritization. Contribute to the Launch Readiness Plans by providing detailed understanding of the regulatory process and by providing guidance on the best regulatory approach (e.g., Labelling, packaging, mockups and artworks). Manage entire regulatory submission process including planning, coordination, preparation, application, electronic submission and post-approval monitoring. Carry out any other tasks as required by the regulatory function to achieve its mission and objectives (e.g., authoring, review and approval of documents, update of databases such as RIMS, LOQ, HA Interactions, MLR review, coordinate linguistic reviews, support Risk Management Plan (RMM, REMS), support IP as needed). Manage change control evaluations for the biosimilar products. May serve as back-up for head of RALs biosimilar. Drive third-party collaborators for Regulatory tasks, including set up of the interaction Mentor Junior RALs. Job Requirements: Bachelor’s Degree in life science or related disciplines 10+ years of experience in international regulatory. Experience managing international or regional regulatory submissions, normally a full global submission (new product application), preferably US BLA or EU MAA Familiarity with regulatory agency interactions including management of the associated documentation and rehearsals Advance knowledge in preparation and coordination of regulatory strategy plans. Experience in biological product development. Experience in CTA requirements. Understanding of Regulatory Affairs contribution to Pharma business. Fluent command of spoken and written English; additional language skills welcome. 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 company’s 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 driver’s 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.