To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02935

About our client Our client is small private company that specializes in developing therapeutics for endocrinology, bone loss and neuromuscular disease. They have a strong pipeline as well as great leadership and culture. This opportunity is great for someone who is hands-on and is looking for a sense of ownership and accomplishment. Position Location Vice President of Regulatory Affairs Cambridge, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Prepare clinical-trial applications and registration dossiers 2) Interact with the FDA 3) Conduct meetings 4) Prepare INDs and NDAs 5) Negotiate with regulatory agencies Requirements 1) Bachelor's degree/Ph. D. in a scientific or related discipline 2) Relevant industry experience 3) Minimum 10 years of experience in successfully leading drug development efforts within the pharmaceutical or biotechnology industry 4) Experience in early- and late-phase drug development process, leading to marketing approval a plus 5) Experience in building clinical strategy 6) Pre-clinical, IND, CMC and BLA submission experience 7) Knowledge of pre-IND, IND and NDA associated with the development process 8) In-depth understanding of and experience in FDA regulations 9) Knowledge of non-clinical pharmacology 10) Excellent speaking and persuasive skills (at appropriate FDA and international regulatory meetings) 11) Ability to do the submission work (hands-on)