Responsible for the effective and efficient management of the regulatory staff at multiple sites. S/he mentors and provides regulatory guidance to team members. This includes projecting and achieving timely regulatory filings, the development of realistic regulatory timelines in the unit and project planning. The Sr. Manager interacts with all levels in the organization, including representing Regulatory Affairs in international and company forums. S/he participates in discussions with Sr. Management and provides strategic regulatory guidance. The Sr. Manager interfaces with regulatory agencies, primarily the FDA, as it relates to submissions and other relevant topics. Maintains regulatory compliance and provides regulatory guidance on development and marketed product issues.
Helps staff to interpret changing priorities, processes and requirements •Leads the development of procedure or tools to increase work efficiency •Translates strategic goals into group and individual performance objectives •Motivates and encourages by recognizing accomplishments •Align resources and develop processes to ensure timely submissions •Applying expert knowledge of industry conditions and opportunities for competitive advantage to make business recommendations •Anticipates changes in the regulatory environment and the potential impact to FK, shaping internal strategies accordingly •Propose and negotiate complex and technical issues to a successful outcome •Provides comments and perspective on proposed regulations to influence outcomes •Promptly recognize performance gaps and resolve them before they impact business results •Supports learning opportunities and mentors others, encourages employees to take on stretch assignments. •Clearly and convincingly communicates complex issues to internal and external customers •Manages timelines and performance for staff at multiple sites and ensure collaboration and consistency across sites within processes. •Additionally, the Sr. Manager will have achieved and garnered the respect of others within and outside the department on matters related to development and marketed drug applications •Recognizes early developing adverse trends or gaps and brainstorms practical solutions for both short and long-term corrective actions. •Collaborates with other FK units in providing RA strategy/expertise •Serves as a technical back up to Director/Sr. Director in matters involving Regulatory strategy •Serves as a backup to departmental functions (meetings, presentations, etc.) •Establishes new procedures while working in unfamiliar or gray areas of Regulatory •Proposes and negotiate complex and technical issues to a successful outcome •Provides comments and perspective on proposed regulations to influence outcomes
•At minimum, a Bachelor Degree in a scientific discipline and 6-8 years’ experience in pharmaceutical Regulatory Affairs with past leadership experience. Relevant experience in other technical areas within the pharmaceutical industry may be considered. •Experience in preparing and filing complete A/NDA’s, Supplements, Amendments and Annual Reports to FDA. Relevant experience in preparing documents that support regulatory filings may be considered. •Previous leadership experience required, with experience in managing multiple levels of staff at multiple site is preferred. •Demonstrated effective oral and verbal communication skills, attention to detail, and superior organization skills. •Demonstrated in depth knowledge in FDA regulations, ICH guidelines, and cGMPs. •Must be detail oriented, self-motivated, organized and have the ability to prioritize work. •RAC beneficial
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, 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, disabilities, or protected veteran status.
Internal Number: R000026
About Fresenius-Kabi USA, LLC
Fresenius Kabi is a global health care company that specializes in lifesaving medicines and medical 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. We are part of Fresenius SE, a health care group with more than 100 years of experience in pharmaceuticals, medical devices and life sciences. Our employees – more than 30,000 worldwide – develop and deliver injectable pharmaceuticals and infusion systems; blood collection, transfusion and cell technologies; and essential nutrients for parenteral nutrition.
Whether you work for us, buy from us, partner with us, or invest in us, you will come to know that caring is at the core of everything we do. Our purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.