Regulatory Submissions Manager
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The Regulatory Submissions Manager will be responsible for managing regulatory submission projects, reporting to the Associate Director, Regulatory Affairs Project Management. This individual is expected to have strong project management skills, combined with a working knowledge of global regulatory dossier practices and requirements, in order to drive execution of submission content plans through collaboration with cross-functional team members. The Regulatory Submissions Manager will ensure team alignment on submission content plans and is accountable for submission timelines for given projects. This individual is responsible for tracking progress of all components of a regulatory submission dossier. They act as subject matter expert for producing a dossier based on submission strategy, and ensure compliance to required format (i.e. eCTD, NEES, paper, etc.).The Regulatory Submissions Manager must have Regulatory Affairs experience working in global markets, across various application types (CTA, IND, NDA, BLA, MAA, etc.) and across all stages of product development.
Roles and Responsibilities
– Independently manage various regulatory submission projects, including development of submission content plans, with minimal guidance
– Actively manage submission timelines, including timelines for completion of certain submission components
– Lead and drive cross-functional teams focused on the identification, planning and execution of regulatory submissions, anticipating regulatory obstacles and emerging issues and developing solutions, including end-to-end submissions throughout a product's lifecycle (i.e. early/late development, post-marketing, etc.)
– Lead and facilitate submission planning meetings effectively, ensuring clear communication of actions and decisions to the team
– Enter and track project and submission data in Regulatory Information Management system
– Work directly with regulatory leads and liaisons in developing submission content plans, and generating certain regulatory administrative components
– Work directly with publishing colleagues and vendors, to ensure an accurate and quality assembly of submission dossiers
– Provide input, participate, and/or lead department initiatives with a focus on ongoing improvement of regulatory submission management processes and tools, developing and contributing to new regulatory processes and SOPs and support training of key personnel, as needed
– Monitor impact of changing regulations on submission strategies and update internal stakeholders
Requirements:
QUALIFICATIONS AND BACKGROUND REQUIREMENTS
– BS or MS in scientific discipline or equivalent required. Project Management certification (i.e. PMP) and/or RAC certification preferred.
– 3-8 years of regulatory affairs experience with drugs and/or biologics; at least 2 years' experience in regulatory submissions management; at least 1-2 years' experience in global markets.
– Experience in managing projects, and leading teams in the development and execution of submission content plans.
– Proficient in the use of the Microsoft Office Suite, Adobe Acrobat, a recognized Project Management application, document and registration management systems, eCTD viewers and other web based applications.
– Working knowledge of global regulatory practices, electronic submission guidelines and requirements, and various submission and registration types.
– Excellent interpersonal skills and written and oral communications skills.
– Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously.
– Experience leading cross functional teams.
– Must be able to innovate, analyze, and solve problems with minimal supervisory input.
