Regulatory Affairs Project Specialist (Somerville, NJ) (multiple positions). Provide regulatory and CMC expertise related to the design and implementation of strategies for the development of new drugs and/or combination products (drug/drug or drug/device). Provide regulatory guidance and submission strategy to clients based on FDA, EU and ICH guidelines. Interact with FDA as US agent/regulatory agent for designated ex-US and US clients, respectively. Prepare and review documents for regulatory submission; compile regulatory dossiers for submission to FDA and/or global health authorities, including but not limited to IND, NDA, BLA, amendments, supplements. Work on multiple assigned projects and communicate project specifics with clients. Prepare or review documents for submission to regulatory agencies. Requires Bachelor’s degree or foreign equivalent in Pharmacy, Biochemistry, Pharmaceutical Engineering or a related field, and three years of experience in the job offered or related position at a pharmaceutical company. Also requires three (3) years of experience with each of the following: (1) reviewing, compiling, and authoring ANDAs, NDAs and supplements/amendments; (2) preparing CMC sections for drug products; (3) assessing drug development plans and proposing regulatory strategies; (4) applying cGMP / cGLP and ICH guidelines for INDs, NDAs and ANDAs; and (5) using electronic Common Technical Document (eCTD) and Structured Product Labeling (SPL). Send resume with cover letter to B&H Consulting Services, Inc., Attn. R. Pereira, 50 Division Street, Suite 206, Somerville, NJ 08876. No calls.

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