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Job #03025

About our client Our client is a dynamic and growing, independent contract drug development and consulting company. Employees at this company are experienced and highly qualified team players, essential to its success. Position Location Director of Regulatory Affairs Texas Salary Highly competitive package, commensurate with experience Responsibilities 1) Direct/handle regulatory project management 2) Provide regulatory counsel for internal and external drug development programs 3) Manage projects to budgets and timelines 4) Provide leadership in non-clinical, clinical or CMC areas 5) Prepare and submit INDs, ANDAs, NDAs, 510Ks, PMAs, BLAs and submissions/approvals 6) Facilitate understanding of electronic submissions including core dossier 7) Work with the VP of Regulatory Affairs in developing and implementing strategy to maintain an efficient and compliant Promotional Review Board (PRB) process 8) Liaise with the FDA (external) and with Marketing/Regulatory/Medical/Sales and Legal (internal) for supporting initiatives as well as processing PRB and reviewing promotional materials 9) Develop and maintain positive rapport and working relationships within and across departments 10) Provide high-level consulting services 11) Hire, train and lead Regulatory staff 12) Ensure the success of the company's India operations Requirements 1) Bachelor’s degree in a relevant field (Pharm.D. or Ph.D. preferred) 2) 7 years of experience in the pharmaceutical, drug and/or device industry (with emphasis on regulatory drug development) 3) 5+ years of experience in a managerial role 4) Experience in NDAs including preparing documents for eCTD submissions 5) Experience in managing offshore staff (India preferred) 6) In-depth knowledge of and experience in a RA Department 7) Knowledge of all FDA regulations to support filings (as they apply to preclinical and clinical disciplines) 8) Proficient in computer and database management 9) Ability to write and establish policies and procedures 10) Excellent communication skills (verbal and written) 11) Willingness to travel internationally – up to 40%