Responsible for assisting with the process of guiding new drug products through early-phase development work through submission of a New Drug Application. This includes regulatory compliance for early submission, product registration, labeling, and advertising compliance for the company both internationally and domestic. Assistance with regulatory filings for medical devices may also be required.
Professional Qualifications
Education
B.S. degree in Regulatory Science or a related technical field preferred.
Experience
Minimum 3 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.
General
Thorough understanding of the CFR, FDA/ICH guidelines and cGMP's, as they pertain to pharmaceuticals in the United States and internationally, including registration, 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 emphasis on preclinical, clinical, and commercialization operations.
High Attention to detail and accuracy.
Position Responsibilities
Specific
Liaise with Regulatory SME and the FDA/other Health Authorities to guide LI-COR products through the regulatory process up through approval.
Prepare FDA applications with the project team including INDs and NDAs.
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.
Review detailed scientific information and assess whether technical justifications are presented clearly and conclusions are adequately supported by data.
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.
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.