Regulatory Operations, Submission Project Manager

Position Summary:Responsible for managing the regulatory document planning and submission process, for all assigned projects/products throughout the product lifecycle, to ensure that non-clinical; chemistry, manufacturing and controls (CMC); clinical; and product labeling information meets applicable regulatory requirements (US and ex-US).Major Duties and Responsibilities: • Support submission planning team in planning, scheduling and coordinating regulatory submission development, based upon thorough knowledge of applicable regulations. • Implement the regulatory submission strategy and drive the submission plan. • Manage and lead the people, processes and technology required to facilitate the production and management of the regulatory submissions to include resource management, team composition and communication while maintaining positive relationships. • Manage and report submission updates against milestones. o Identify areas of risk of jeopardizing the timeline. o Identify areas of resolution to timeline issues. • Manage the submission process by ensuring that planned regulatory submissions are progressing in a timely fashion. • Interface with Regulatory Affairs and Regulatory Publishing staff to coordinate the development of assigned submission projects. • Manage the assembly, review and technical approval for regulatory dossiers and documents for assigned products. • Coordinate the submission of high quality, “Right First Time� dossiers to achieve maximum product claims and competitive advantage. • Contribute to the implementation, maintenance and continuous improvement of the submission process in the ICH regions. • Identify appropriate resources needed to support submission activities. • With input from functional leaders, create a detailed multi-disciplinary project timelines. • Work to ensure electronic assembly of all submissions are planned, coordinated, and delivered on time, and adhere to company and Agency standards: • Develop and manage submission plans through the use of project management tracking and planning tools. • Ensure the use of appropriate document policies and standards to create “Regulatory Submission Ready� documents. • Promote standardization of submission processes within the organization. • Anticipates and identifies regulatory and project development risks and makes recommendations to senior management regarding alternatives for risk mitigation. • Communicate with external contractors to inform them of technical requirements for source documents, through the provision of templates and company policies and standards, and by way of timely updates or changes. • Maintain submission-tracking process in support of short- and long-term submission and resource planning. • Assist with other Regulatory Operations department activities as required.Requirements/Qualifications:Education: B.S. or B.A degree in science related field, advance degree desirable. Experience/Qualifications: • Minimum of 5 years drug development/regulatory experience, including demonstrated experience in project management and regulatory submissions. • Clear understanding of US and ex-US requirements with regard to submission content and format is required. • Superior negotiation and influencing skills. • Ability to multitask and manage multiple and changing priorities. • Highly self-motivated individual and self-starter, independent worker. • Experience in Project Management and use of project planning and software tools. • Ability to work under pressure and adhere to deadlines. • Computer proficiency in Microsoft Office required, including: Word, Excel, PowerPoint, Project, Outlook and Visio. • High analytical evaluation skills. • Excellent communication (both verbal and written) and human relation skills. • Excellent people and project management skills, with ability to prioritize and delegate, handling several projects concurrently. • Fluent command of spoken and written English. Job Complexity: Work on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors. Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.Supervision: Manages and coordinates regulatory submission projects, works independently with supervision. MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. Job Title: Regulatory Operations, Submission Project Manager Company:  MedImmune Inc. Location:  Gaithersburg, MD 20878 Status:  Full Time, Employee Job Category:  Biotech/R&D/Science Company: MedImmune Inc.