Regulatory Consultant/Nonclinical

Location: Denver Consulting

Job Description

This role will have the responsibility for ensuring technical conduct of a wide range of Nonclinical Safety Studies, from discovery through development projects. This role will have direct responsibility for the design of product development strategies for biologics, gene and cellular therapies focusing on nonclinical product development. This role will contribute to development of gap analyses, indication prioritizations, target product profiles, nonclinical, nonclinical study designs, author and review documents for regulatory meetings and submissions, and other work products.

Responsibilities
• Hands-on review and/or creation of nonclinical product development strategies to meet regulatory requirements for first-in-human and/or registrational clinical studies
• Strategic regulatory guidance, including integrating nonclinical information to appropriately time and design clinical studies to address safety related issues, in particular safety & efficacy interactions.
• Provide interpretive guidance for strategic decision making critical for safety, marketability and regulatory requirements
• Utilize extensive expertise in toxicology & DMPK to evaluate toxicokinetic responses identified in nonclinical product development and guide subsequent evaluation in clinical studies for safety related issues.
• Review product development strategies (both nonclinical and clinical) to assess compliance with EPA, FDA/EMA guidance, regulation, and applicable drug law, GLP, ICH
• Manages meetings/expectations with Regulatory Agencies
Required Knowledge, Skills And Abilities
• Held positions of increasing responsibility in the pharmaceutical, biotechnology and/or CRO sectors
• Extensive experience in development of nonclinical regulatory strategy and development plans
• Strong experience in regulatory agency interaction
• Biotechnology, Gene and Cell Therapy experience
• Extensive expertise in toxicology & DMPK
• Expertise in Good Laboratory practices, worldwide regulations, safety assessment SOP’s, protocols, policies and procedures
• Extensive experience in regulatory and/or technical writing and/or process management
• Ability to make difficult judgment calls within sphere of responsibility. Demonstrates advanced negotiating, influencing and motivating skills
• Strong software and computer skills, including MS Office applications

Minimum Required Education
• Advanced degree in life science-related discipline or professional equivalence
• Extensive strategic nonclinical regulatory experience, or combination of education, training and experience


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