Responsible for global regulatory affairs strategy for assigned projects covering the development, registration and post approval phases, and acts as liaison with the health authorities including the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) review divisions. Works closely with other functional areas to develop regulatory strategies and timelines, including regulatory operations, project management, clinical development and pharmacovigilance.
Strong experience in clinical operations and research and related US regulatory experience
Lead clinical development and regulatory strategy for drug, biologics and devices. Provides advice and direction including identifying and assessing regulatory risks regarding regulatory requirements and strategies
Develops and executes effective proactive regulatory strategies and plans
Ability to support the product strategy team to assess whether technical arguments are presented clearly and conclusions are supported by data and their associated risk assessments.
Reviews documents and work closely with Regulatory Operations to publish the final regulatory submissions to FDA CDER review divisions
Primary contact for assigned projects with key personnel in FDA review divisions for assigned projects
Plans, coordinates and leads meetings with Regulatory Authorities (e.g., Pre-IND, End of Phase 2, Pre-NDA, Scientific Advice and national advice) including meeting requests, meeting background documents and action plan following such meetings
Maintains knowledge of the laws, regulations and guidelines governing drug development and approval
Manages and reviews clinical, safety and other reports and submissions
Advanced degree in health care (ex. pharmacy, clinical, biologics)
A minimum of 10 years of pharmaceutical industry experience with 8 years of regulatory experience
Previous management experience is preferred. Must demonstrate the ability to work effectively with others
Must demonstrate understanding of drug, device and biologics development and knowledge of FDA requirements. Working knowledge of scientific principles
Direct experience with FDA required and international experience preferred
Leadership role on project teams with approximately 40% of time in meetings
Highly organized with attention to detail. Strong verbal and written communication skills are required, as well as excellent scientific writing, presentation and documentation skills
Has familiarity with MS Word, Adobe Acrobat and PowerPoint applications.