MALLINCKRODT ENTERPRISES, LLC Manager Regulatory Operations in Webster Groves, Missouri
JOB DESCRIPTION SUMMARY OF POSITION: This position will manage the Regulatory Operations team within the Regulatory Affairs function for the Specialty Generics business unit of Company . This position is responsible for oversight and support of regulatory submissions and the development of Regulatory Operations practices; overseeing publishing and submission of INDs, briefing packages, ANDAs / 505b2, DMFs, supplements, annual reports, safety reports, amendments, etc. In addition, this position is responsible for developing and directing objectives, policies, and programs pertaining to department software initiatives. ESSENTIAL FUNCTIONS: * Ensure all publishing and submissions are undertaken effectively in compliance with timeline requirements * Develop strategy for use of electronic document management software EDMS within Regulatory and all applicable departments, direct administration of the EDMS, address user requirements and upgrades for the system. Serve as primary point-of-contact. * Provide timelines to Project Teams and key Regulatory stakeholder regarding submission timelines * Maintain current working knowledge of FDA and other global regulatory requirements * Work to establish and maintain process around use of the Regulatory Information Management system, InSight Manager. Determine strategy for global use of the system and manage the entire system. * Work with vendors and various departments on multiple software projects, including new installation and upgrades, serving as the business lead and primary point-of-contact. * Participate in project team meetings and provide status updates of Regulatory Operations activities, represent the company s Regulatory Operations group in internal and external development project meetings and contribute to the establishment of regulatory strategies for new products and processes * Mentor staff internal and external to the department * Provide regulatory advice and interpretation of submission regulations and guidance to Regulatory Affairs staff and team members * Develop and implement SOPs and/or work instructions * Other duties as assigned with or without accommodation. MINIMUM REQUIREMENTS: Education: Bachelor s degree in scientific discipline Experience: * At least 8 years of experience in Regulatory Affairs, with at least 6 years of experience in Regulatory Operations * 3 to 5 years of managerial experience * Experience with electronic submission software Insight Publisher preferred and EDMS systems Documentum, NextDoc preferred. * Knowledge of IT systems and electronic submission requirements and processes for FDA and other global health agencies, for pharmaceuticals, biologics, and medical devices Skills/Competencies: This position reports to the Director, Regulatory Affairs and will have managerial responsibility for the Regulatory Operations team WORKING CONDITIONS: Standard office environment Possible travel to other Company locations #LI-KS1.Mallinckrodt Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.Employer's Job# JR000007481Please visit job URL for more information about this opening and to view EOE statement.