Regulatory Technical Manager

Fresenius Kabi USA, LLC
$110,000-125,000
life insurance, 401(k)
United States, Illinois, Lake Zurich
3 Corporate Drive (Show on map)
Apr 15, 2025
Job Summary The Regulatory Technical Manager (clinical/non-clinical) has responsibility for strategy development and regulatory review of clinical and non-clinical information This position interacts with all levels in the organization and participates in discussions with management and provides strategic regulatory and clinical/nonclinical guidance. The regulatory technical manager (clinical/non-clinical) interfaces with regulatory agencies, primarily the FDA, as it relates to clinical/nonclinical issues and other relevant topics. The Regulatory Technical manager reports to the Director of Regulatory Affairs. This role does not have any direct reports. Salary Range: $110,000-125,000 Position is eligible to participate in an annual bonus plan with a target of 10% 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 Define and implement regulatory strategies for products in development related to clinical and nonclinical aspects. Revises regulatory strategy as necessary based upon scientific data, changes in the regulatory environment, global project direction, etc. Support labeling development discussions and leads labeling extensions/updates for NDAs. Anticipate and prepare appropriate mitigation strategies. Recognize early developing trends or gaps and brainstorms practical solutions for both short and long-term corrective actions. Perform research on other regulatory precedents to support the development of regulatory strategy for the assigned clinical/nonclinical development program. Represent regulatory affairs on project teams and providing regulatory guidance and support in drafting clinical/nonclinical submission documents Provide expertise in translating regulatory requirements into practical, workable plan Apply expert knowledge of industry conditions and opportunities for competitive advantage to make business recommendations. Interact and use effective communication to influence regulatory agencies regarding submission strategy. Outline and coordinate preparation of and drafting of FDA meeting packages. Mentor and coach others regarding the regulatory requirements, including the clinical/nonclinical development phase. Review technical documents for cGMP and regulatory compliance. Job Requirements Bachelor's degree in a scientific discipline (e.g., Life Sciences, Pharmacy, Biotechnology, Pharmacology); Advanced degree preferred. 8+ years of related experience in pharmaceutical within Regulatory Affairs Experience in authoring and preparing INDs, A/NDAs, and Amendments to FDA Thorough understanding of the CFR, FDA/ICH guidelines and cGMPs, as they pertain to pharmaceuticals Ability to effectively influence at all levels of the organization RAC beneficial 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, andwellness 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.