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Job #02982

About our client Our client is a young venture-backed pharmaceutical company headquartered in Massachusetts that is using a science-driven approach to develop novel therapeutics to treat a number of large, poorly served dermatological disorders. The company has premier investors and an experienced management team that is committed to the highest standards of integrity and to improving the lives of patients and their families. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Regulatory Affairs Manager Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide leadership, direction and focus for the company's drug development programs (from a regulatory perspective) 2) Participate (actively) and oversee filing of all the company's INDs and NDAs 3) Interface with regulatory authorities at all appropriate stages of clinical development to ensure the regulatory success of the company's clinical research programs 4) Manage all the regulatory processes within the company 5) Coordinate with outside CROs and consultants to facilitate all aspects of the company's clinical programs with respect to regulatory compliance 6) Build an effective development team capable of aggressively achieving established goals on time 7) Participate in identification, analysis and due diligence on future in-licensed drug candidates 8) Provide overall medical input into the viability of products from a regulatory perspective 9) Act as a key spokesperson to investors regarding regulatory pathways affecting the company's clinical strategy and development programs Requirements 1) MD/Ph. D. 2) Minimum 7 years of experience in a biotechnology or pharmaceutical company 3) Experience in a development stage venture (dermatology preferred) 4) Experience in dealing with FDA advisory panels 5) Knowledge of regulatory and clinical development process 6) Understanding of global clinical trials and the regulatory filing process 7) Current knowledge of FDA and ICH regulations as well as GCP guidelines 8) Expertise in preparing and filing INDs and NDAs, resulting in drug approvals 9) Excellent project management and problem-solving skills 10) Superb communication skills 11) Ability to articulate the company's clinical strategies and progress to a wide audience including the CEO, the Board of Directors as well as the investment, medical and regulatory communities 12) Proactive with result-oriented work ethic and a positive can-do attitude 13) Hands-on attitude with ability to work with both peers and subordinates 14) High energy level with ability to focus and prioritize 15) Highly analytical with ability to be decisive and collaborative 16) Impeccable personal values and ethical standards