Clinical Trials, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
4 Year Degree
Responsible for regulatory compliance, product registration, labeling, and advertising compliance for the company both domestic and internationally.
Lead, develop and implement regulatory strategy to meet LI-COR goals and objectives.
Respond to changes in the regulatory environment and make strategic recommendations to minimize risk to the business.
Interpret Regulatory Authority policies, guidance and correctly apply them as appropriate in product development.
Ability to take innovative ideas from proof of concept to promote a successful product regulatory submission and increase probability of regulatory approval.
Review detailed scientific information and assess whether technical justifications are presented clearly and conclusions are adequately supported by data.
Assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.
Create and maintain regulatory timelines to ensure that regulatory submission timelines are met.
Interface with functional areas (Clinical, Nonclinical, Commercial) to identify and obtain information required for regulatory submissions.
Prepare FDA application with the project team including INDs and NDAs.
Serve as primary liaison for FDA communications regarding filings.
Lead international product registration and interpret regulatory rules as they relate to company product and procedures, clinical studies, testing or records keeping and ensure that they are communicated through company policies and procedures.
Procure and oversee outside vendors and Regulatory Consultants as required.
B.S. degree in Regulatory Science or a related technical field preferred.
Minimum 7 years’ knowledge and experience in Regulatory Affairs in the pharmaceutical industry, with a proven track record of successful submissions to FDA of INDs and NDAs.
Thorough understanding of the CFR, FDA/ICH guidelines and cGMP’s, as they pertain to pharmaceuticals in the United States and internationally, including registration, and labeling requirements. Understanding of FDA QSR, medical device manufacturing and ISO/EC requirements preferred but not required.
Knowledge of pharmaceutical industry regulatory affairs throughout the product lifecycle, with awareness of preclinical, clinical, commercialization, and operations.
High attention to detail and accuracy.
Telecommuting is allowed. Employer will assist with relocation costs.
Internal Number: 0001
About LI-COR Biosciences
LI-COR technology enables scientists around the world to improve lives by advancing discovery. From the first low-cost light sensor filtered for the waveband absorbed by plants, to pioneering the development of near-infrared fluorescence detection systems for DNA sequencing, LI-COR strives to provide innovative solutions for researchers.
Today, LI-COR Biosciences is a leading innovator in systems for plant research, gas analysis, drug discovery, protein research, and small animal imaging.