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 #02510 About our client Our client, a biopharmaceutical company, focuses on developing therapeutic products, for the medical needs of patients with debilitating conditions and life threatening diseases. The programmes of the company are intended for gastroenterology as well as treating HIV infection and cancer. The company has many products in the development and pre-clinical development stage. Position Location Associate Director of Regulatory Affairs New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop and execute RA plans for small molecule programs 2) Work closely with Non-Clinical, Clinical, Manufacturing, Quality and Project Management personnel 3) Support preparation of regulatory documentation 4) Assist in maintenance of INDs 5) Organize IND and NDA meetings 6) Prepare FDA communications 7) Participate in project teams and exercise expertise and judgment in providing guidance to other personnel 8) Keep abreast of regulatory requirements for small molecules 9) Interface with CMC, non-clinical, clinical and RA partner groups to ensure compliance for all assigned programs Requirements 1) 5-10 years of experience in regulatory affairs 2) Experience in antibodies, vaccines or gene therapy preferred 3) Experience in post-marketing activities preferred 4) Experience in eCTD NDA 5) Solid working knowledge of cGLP, cGCP, cGMPs and eCTD, 6) NDA experience in regulatory affairs with an emphasis in the small molecule drug area 7) Experience in small molecules 8) Experience in INDs NDAs (eCTDs) and interfacing with FDA (CDER and/or CBER) 9) Experience in preparing electronic drug submission, i.e. eCTD NDA 10) In-depth knowledge of drug development, including CMC, pre-clinical and clinical development
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