Aerovance is a biopharmaceutical company focused on the development and commercialization of clinical-stage products for serious and life threatening lung disorders. The company was spun off from Bayer Healthcare’s biotechnology unit and founded in 2004 by Wolf-Dieter Busse, in partnership with Apax Parnters, Lehman Bothers, NGN Capital, and Burril & Co. In May 2006, Aerovance secured Series C financing led by Clarus Ventures with participation from Alta Partners. Aerovance is a privately held biopharmaceutical company exclusively focused on developing and commercializing biotherapeutics. The company maintains a solid intellectual property position with its strong portfolio of potential breakthrough products now in clinical development and several pre-clinical programs. The lead products are human recombinant proteins: Aerovant™, an IL-4 and IL-13 receptor antagonist currently in Phase 2a studies for asthma; Aerolytic™, a serine protease inhibitor in Phase 2a for Cystic Fibrosis; Aeroderm™, an IL-4 and IL-13 receptor antagonist in Phase 2a for eczema, and Pulmolytic™, a serine protease inhibitor in Phase 2a for COPD. Aerovance’s goal is to build a fully integrated global company that applies new inhalation technologies, including the discovery, development and commercialization of novel inhalation molecules for serious and life-threatening lung disorders. Aerovance’s lead compounds are currently completing Phase II trials for the treatment of severe uncontrolled asthma, cystic fibrosis, severe chronic obstructive pulmonary disease and severe unresponsive eczema. The consultant opportunity for Regulatory Affairs will provide regulatory strategy and support for research, development, and clinical projects. He/she will be expected to: Work collaboratively across a broad range of people, functions, and disciplines to achieve strategic goals (this assignment is 2 days per week in-house). Lead creative and constructive interactions with regulatory agencies to ensure that all projects have clearly defined regulatory paths and milestones leading to successful filings and approvals. Plan and lead the compilation of all relevant regulatory filings and responses to health authorities. Organize and lead the communication and interactions with all regulatory agencies for all development and clinical projects. Effectively utilize outsourcing to achieve project goals in a timely manner. Participate in higher level interactions with external partners. Provide advice to the project teams on regulatory matters for GMP, GLP, and GCP aspects of all research, development (manufacturing and operations), pre-clinical and clinical. Requirements Must be on-site 2 days per week. A bachelor or Masters Degree in a scientific discipline is required. A minimum of 10 years experience in the regulatory affairs (or related role) in the pharmaceutical industry. Experience with biological products (antibodies, proteins, etc.) is required. Experience with both US and ex-US regulatory filings. Experience with multiple regulatory disciplines (CMC, clinical, labeling, etc.). Excellent oral and written communication skills. Qualified candidates should send their resume to Terri Zelmer, terri.zelmer@aerovance.com Aerovance offers a competitive compensation package including stock options, outstanding medical/dental/vision care, PTO, and a friendly, team-orientated work environment.