FierceBiotech and FiercePharma Jobs
Sr. Director, Regulatory Affairs - Advantage ONE Executive Search
Nov 04
Location: Washington, Categories: Clinical
Position Description
Regulatory Affairs, Sr. Director
Greater DC Area OR Princeton, NJ
Our client is a well established mid-sized international pharmaceutical company with in-line products and a robust pipe-line.
Responsibilities
Provides regulatory expertise and support for pre-clinical and clinical areas for investigational and marketed products. Ensures development of the drugs are in accordance with global regulations in order to approve drugs quickly and smoothly within typical approval timeframes. Ensures marketed products are supported with minimal questions and issues from the regulatory agencies. Establishes well-defined regulatory pathways and creates accurate and timely documents for IND and NDA submission and final approval. Provides strategic regulatory leadership and guidance to the project teams. Designs programs for complete and accurate IND submissions and ensure that clinical trials as designed meet regulatory requirements. Defines regulatory expectations for teams, identifies elements of INDs and FDA required preparation, positions response to regulatory agencies, defines strategy for negotiations and formal document submission, and provides strategic input in the development of the plan. • Interacts with regulatory agencies and ensures conversations and communications are focused, amicable and documented.
Knowledge
• Comprehensive knowledge of the drug development process, labeling and promotional reviews, drug laws, global regulations and guidelines.
• Comprehensive understanding of the global regulatory agencies.
• Proven success of submitted SNDA, IND and NDA.
Requirements
PhD with 10 years of experience in clinical drug development in pharmaceutical industry, including 6 years of supervisory experience.
OR
MS/PharmD/DVM with 15 years of experience in the pharmaceutical industry and 8 years of supervisory experience.
Experience in leading FDA meetings across multiple FDA divisions.
If fully qualified, reply to lvaughn@advantage-search with your confidential resume attached as an MS Word doc
