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Job #02952

About our client Our client is a biopharmaceutical company based in Westminster, Colorado. They focus on the development and commercialization of small molecule therapeutics for the treatment of cancer. Their team is dedicated to patients and the customers they serve. They want to attract, develop and retain world-class talent to build a high-performance organization. This is a great opportunity for the right candidate! Position Location Associate Director of Regulatory Affairs Westminster, Colorado Salary Highly competitive package, commensurate with experience Responsibilities 1) Plan and lead all regulatory activities for assigned project(s) or territories in compliance with ICH and regional requirements as well as corporate objectives 2) Manage and oversee regulatory interactions for assigned project(s) (work closely with external contractual organizations and/or partners outside the US) 3) Prepare (or manage preparation of) regulatory submissions to obtain and maintain clinical trial applications as well as marketing authorizations for assigned product(s) and territories 4) Participate in preparing product label and core data sheet for assigned project(s) or territories to align commercial objectives with available as well as expected scientific data, regulatory guidance and precedence Requirements 1) BS/MS/Ph. D. in a scientific discipline or equivalent experience 2) Minimum 8 years of experience in regulatory affairs (or related pharmaceutical experience) 3) Experience in working with regulatory authorities (USA and Europe preferred) 4) Experience in preparing and marinating US and/or European clinical trial applications and/or marketing applications (eCTD) 5) Experience in working on project teams 6) Expertise in providing regulatory guidance to cross-functional departments 7) Knowledge of all aspects of RA 8) In-depth knowledge of US and European clinical trial as well as registration requirements 9) Hands-on leadership skills 10) Expertise in working with non-clinical, clinical, manufacturing, quality and project management to prepare regulatory documentation (high-growth, fast-paced pharmaceutical environment)