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Job #03465

About our client Our Client is a biotechnology company focused on developing multiple platform approaches to the treatment of several cancers and HIV. Their lead products in development represent a market potential in excess of $10 billion. With a highly experienced management team and several products in their pipeline, this is an exciting opportunity for the right person to join a fast paced environment Position Location Director of Regulatory Affairs New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Contribute (proactively) to formulating global regulatory strategies that interpret and reflect regulatory as well as corporate guidelines 2) Plan and execute all US and International filings 3) Work with collaborating Investigators in the filing and execution of Investigator INDs 4) Plan and execute the migration of Investigator IND to corporate IND 5) Plan, manage and implement regulatory programs in multi-disciplinary project teams 6) Represent the company at FDA, EMEA, DDMAC and other regulatory agencies 7) Oversee and maintain all corporate records in a manner capable of passing regulatory audits 8) Initiate/respond to regulatory agency contacts (e.g. telephone, email, meetings, etc.) to negotiate successfully and achieve business objectives 9) Manage and account for regulatory reviewing of promotional materials as well as ensure regulatory compliance of product brand 10) Review global product promotional materials and press releases 11) Ensure that all documents to be submitted to regulatory agencies are timely and complete 12) Ensure compliance with all agency-regulated development and post-approval activities including timely and accurate submissions of annual reports as well as supplemental filings 13) Build and maintain strong business and working relationships with internal/external groups 14) Communicate regulatory status and risks (related to products and compliance) to senior management 15) Ensure that all regulatory and quality-related activities/functions are current, implemented fully and compliant with defined standards 16) Work with internal departments as well as external CROs and CMOs to ensure timely and cGXP-compliant disposition of products 17) Interface directly with regulatory agencies to host regulatory inspections compliance activities by communicating openly and effectively Requirements 1) B. Sc. in Science (Advanced science degree preferred) 2) 5 - 10 years of regulatory experience in the pharmaceutical industry 3) International regulatory experience 4) Experience in biologics and oncology highly preferred 5) Experience working with FDA and government bodies 6) Clinical background a plus 7) Experience writing and submitting INDs 8) Excellent presentation, interpersonal and communication (written and oral) skills 9) Ability to work independently, both as a functional leader and as part of a team