Job Summary The manager has supervisory responsibilities over a team of regulatory professionals for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers. S/he mentors and provides regulatory guidance to team members. The manager interacts with all levels in the organization. S/he participates in discussions with management and provides strategic regulatory guidance. The manager interfaces with regulatory agencies, primarily the FDA, as it relates to submissions and other relevant topics. Responsibilities The manager is responsible for effectively Managing and prioritizing the team's workload in accordance with departmental goals Ensure that CMC teams work effectively and productively and have proper coordination with assigned labeling and publishing members Motivating staff and maintaining the team's focus on departmental objectives Sharing best practices for planning, organization and time management Overseeing the preparation and filing of high-quality submissions to regulatory authorities Ensuring that all applications are filed in accordance with predetermined timelines Providing expert regulatory strategy/guidance to staff and inter-disciplinary project teams Applying expert knowledge of industry conditions and opportunities for competitive advantage to make business recommendations Primary point of contact for FDA on FK US ANDAs Interact and negotiate with FDA regarding strategy and resolution of complex deficiency issues Gathering deep insight into the industry (pharma and/or device) by actively participating in professional organizations Developing quality standards for RA Continually adapting and innovating processes to ensure best practices Ensuring that department management is aware of team activities and progress Developing staff and conducting mid-year and annual reviews of staff Projecting professionalism and a courteous, cheerful and cooperative demeanor Other duties as assigned Requirements At minimum, a Bachelor Degree in a scientific discipline and 4 years’ experience in pharmaceutical Regulatory Affairs Experience in preparing and filing complete A/NDA’s, Supplements, Amendments and Annual Reports to FDA Thorough understanding of the CFR, FDA/ICH guidelines and cGMP’s, as they pertain to pharmaceuticals Well-developed communication skills RAC beneficial Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, and 401K with company match. Fresenius Kabi is an Equal Opportunity Employer. We encourage and support a diverse workforce.
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