July 12, 2018
Cranbury, New Jersey
Full Time - Experienced
Biologics, Biotechnology, Pharmaceuticals, Quality/Risk Management
The Associate Director will be responsible for the development and maintenance of the Target Product Profiles, Company Core Datasheets (CCDS), and regional labeling to lead the strategic development and subsequent submission, launch, and post approval maintenance of clinical and globally marketed products. The Associate Director facilitates the generation of new and revised product labeling with key local and global disciplines as well as external alliance partners and serves as the expert for the regulatory history for labeling communications with FDA and global health authorities. The individual in this position will also support the maintenance of the Migalastat Amenability Website to ensure compliance across applicable regions.
The Associate Director must have Regulatory Affairs experience in pre and post market labeling, experience building labeling processes and teams, possess advanced project management, document management and publishing skills, including use of the Microsoft Office Suite, Adobe Acrobat and a recognized Project Management application. A B.S. or M.S. degree is required (advanced degree preferred) with at least 8-10 years of experience.
Roles and Responsibilities
Leads efforts to create, modify, and review labeling documents, including core data sheet, prescribing information, patient labeling, and packaging/artwork content for use with attention to competitive positioning
Co-ordinates response to labeling-related questions from authorities and convenes labeling working group meetings to reach content consensus with technical experts
Prepares presentations and trains other departments and outside speakers
Responsive to business goals offering creative and compliant solutions while ensuring absolute regulatory integrity and consistency in labeling activities and communications
Works collaboratively with colleagues in the Regulatory Affairs, Medical, Legal, and Commercial team members during labeling development and reviews
Provides upon request analysis of competitor labeling in the relevant therapeutic area
Responsible for continuous quality and compliance throughout the packaging labeling process
Member on project teams and regulatory sub-teams, as appropriate
Contribute to the development and implementation of Corporate and Department procedures and policies for the development of labeling.
BS or MS in scientific discipline or equivalent required.
Advanced degree and/or RAC certification preferred
8-10 years of regulatory affairs experience with drugs and/or biologics
At least 5 years’ experience in pre and post market Labeling development and review
Extensive knowledge of global regulations, guidance documents, and initiatives related to Labeling requirements
Experience and Skills
Excellent interpersonal skills and written and oral communications skills
Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously
Must be able to innovate, analyze, and solve problems with minimal supervisory input
Internal Number: 1325
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Amicus Therapeutics is a global, patient-centric biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare metabolic diseases. We have a unique set of platform technologies and medicines in development for patients living with Fabry disease and Pompe disease. We are also committed to advancing and expanding a robust pipeline of cutting-edge, first- or best-in-class medicines for these and other rare diseases. The needs of patients in the rare disease community are at the center of our inventive science, our commercial organization, and our clinical programs. Our goal throughout all levels of the organization is to make a meaningful difference in the lives of patients and caregivers. Our footprint spans more than 25 countries including our global headquarters in Cranbury, NJ, and international headquarters in Gerrards Cross, UK. International office locations include Canada, Germany, Italy, The Netherlands, Spain, France, and Japan. ****More Jobs Like This
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