Director Regulatory Affairs US IZ
Posted on Nov 17, 2018 by Affinity Executive Search
Direct Reports 2 Mgrs
Indirect Reports: 8 -10
Responsible for coordinating quality regulatory submissions to the United States Department of Agricultures (USDA), specifically The Center of Veterinary Biologics (CVB), and following USDA licensure, coordinating dossier submissions to regulatory authorities in countries, including affiliates and distributors.
Manage US Regulatory Affairs Department:
* Manage and oversee licensure of new products in the US. Oversees timelines for assigned regulatory documentation including initial submissions, meeting requests, protocol assistance, etc.,
* Manage and oversee post-product licensure activities
* Manage USDA labeling. Disseminate approval of labeling and implement system to track official labels.
* In coordination with QA, host and liaise with USDA officials during site inspections and manage responses required to address inspection activities.
* Maintain positive working relationships with the USDA - CVB.
* Responsible for quality of regulatory documentation prior to submission.
* Review, evaluate and provide regulatory guidance and approval for content of promotional materials to ensure quality and fair balance and to remain in compliance with USDA guidelines.
* Ensures compliance for pharmacovigilance (adverse event processing and safety report submissions) to comply with US regulations.
Manage International Zone Regulatory Affairs Department:
Manage and oversee licensure of products globally. Prepare dossiers (USDA or EU-style) concurrently from USDA submissions in order to make timely submissions to strategic and business countries. Recognized expert in US regulatory activities, plus a broad knowledge of related disciplines, theories and principles of biologic vaccines.
Education Degree Prefer Masters or (DVM) or PhD in a medical and/or animal science is preferred.
Work Experience - Minimum 10+ yrs. Regulatory Affairs (specifically working with the USDA and 9CFR) Incumbent needs to have knowledge and experience with The Center of Veterinary Biologics (USDA 9 CFR), and working knowledge of the European Medicines Agency (EMEA), the US Food and Drug Administration (FDA) and other Regulatory Agencies (Canada, China, Japan, Asia Pacific, and Latin America).