Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.  Job #02576   About our client Our client is a biopharmaceutical company dedicated to discovering, developing and commercializing orally active drugs that address significant unmet medical needs. Primarily focused on the treatment of cancer and inflammatory disease, their proprietary drug development pipeline includes several small molecule drug candidates designed to regulate targets in therapeutically important biologic pathways. This company aims to be the most efficient inventor of therapeutic products in the pharmaceutical industry. Position Location Associate Director, Regulatory Affairs Colorado Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide strategic regulatory input for a therapeutic area in the development of small molecules 2) Manage regulatory submission activities for assigned drug products in the US and Rest of the World (ROW) 3) Provide strategic regulatory input on project teams 4) Assist the VP in mentoring of less senior regulatory professionals 5) Provide regulatory expertise on drug development projects 6) Keep abreast of the regulatory environment in the therapeutic area assigned 7) Help in the implementation of necessary infrastructure for the successful completion of regulatory projects 8) Provide input in the selection of vendors (i.e. CROs, regulatory consultants, etc.) Requirements 1) BS/MS in Life Science or equivalent, Ph. D a plus 2) 5 – 7 years of experience in regulatory affairs 3) Thorough understanding of the drug development process 4) Experience in inflammation/pain and/or oncology preferred 5) Ability to work independently, but in a team environment 6) Ability to work on multiple projects simultaneously
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