Coordinates and assembles regulatory and clinical documents for review and submission to FDA in support of a clinical development program
Provides advice in regards to the regulatory strategy for the clinical development program
Responsible for filing IND applications and IND amendments, and for handling all interactions with the FDA.
Participates in the development of organizational strategy to address regulatory affairs.
Develops regulatory procedures to ensure regulatory compliance.
Manages and tracks queries, comments and commitments with FDA and provides periodic status updates regarding unfulfilled conditions/commitments.
Other duties as assigned
Advanced degree in the biological, health, pharmaceutical or regulatory sciences preferred.
5-8 years of relevant FDA regulated industry experience, experience working at the FDA is highly preferred
Experience with filing of IND submissions and supporting NDA submissions, including clinical trials in Phase I/II, for a pharmaceutical product is required
Experience with anti-infectives and interacting with the Division of Anti-Infective Products at CDER is highly preferred
Knowledgeable of FDA Clinical Trial Guidance’s and regulations, pharmaceutical development process, and industry standard practices.
Proficient in written, oral, and interpersonal communications in English
Ability to work in close collaboration with colleagues cross functionally.
High attention to detail; ability to organize and prioritize assigned projects.
Proficient user of standard MS Office suite (eg, Word, Excel), experience using electronic document management systems and document review tools desirable.
Other Knowledge, Skills and Abilities
Written and Verbal Communication Skills - Communication Skills or Ability to: Communicate effectively verbally and in writing
Cognitive Skills - Ability to pay strong attention to detail
Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Think analytically and critically
Detailed oriented and strong organization skill
Judgment and Decision Making
Active Listening - Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate.
Work Environment (Location, travel, shift, on-call, etc.)
The position is located at the company offices in Duarte. The standard work hours are Monday through Friday, between 8 am and 5 pm. Occasional travel to the nearby manufacturing plant in City of Industry is required. This position may require out of town travel of less than 10% of annual work hours.
Regulatory Knowledge (as applicable)
Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Regulatory agency structure, processes and key personnel
Principles and requirements of applicable regulations for pharmaceutical/anti-infective product development
Submission types and requirements in the US for clinical trials
GxPs (GCPs, GLPs, GMPs)
Ability to write and edit technical documents
Research and locate information on regulatory requirements and products
Handle detailed tasks and prioritize them
Work with people from various disciplines and cultures
Review and analyze documentation
Exercise judgment and creativity within defined procedures and practices to determine appropriate action
Develop general knowledge of technical alternatives and gain an understanding of their impact on associated products, systems and the business.