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Ra Assoc. Director/Director - Clinical/Strategy - Regulatory Affairs -Pharma MA Type: Full-Time Category: Regulatory Affairs Job ID: 842 Opportunity Description: ( 617) Area Code                                                            Boston/ Cambridge Area         Associate Director/Director, Regulatory Affairs Reporting to the Vice President of Regulatory, the Associate Director/Director of Regulatory Affairs will work with a cross-functional team to implement regulatory strategy, data and submission packages to US and international regulatory agencies. Responsibilities include actively contributing to the development and implementation of regulatory strategy for specific projects including identifying and assessing regulatory risks, serving as the regulatory representative on project teams, active involvement in the writing and review of regulatory submissions and interfacing with authorities, coordinating all aspects of regulatory submissions and proactively keeping updated on regulatory requirements worldwide. Qualifications A minimum of 8+ years pharmaceutical/biotechnology industry experience, 5 plus years regulatory experience working on biotech programs. * Excellent written and communication skills * Attention to detail * Ability to work independently and within project teams, committees, etc. to attain group goals * Ability to represent the department on project teams * Ability to maintain files and documentation updated and inspection-ready * Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload * Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff * Managerial experience * Experience in interfacing with regulatory authorities * Active involvement in 3 plus IND, NDA/sNDA submissions * Experience and knowledge in the preparation of electronic submissions * CMC experience a distinct advantage * Knowledge and understanding of US and ex-US (a plus) regulatory regulations * Highly computer literate (Word, Excel PowerPoint), including formatting and making the document submission-ready. PhD or PharmD degree preferred but not required. Life/Health Sciences preferred as well   If you are interested in the company name and exact location for this opportunity, please enter your email address below.

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