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Job #02699

About our client Our client is a privately owned biotechnology company headquartered in Maryland that is focused on the development and commercialization of gene therapy solutions. Position Location Manager/Associate Director of Clinical Affairs Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage, prepare and ensure timely submissions of well-organized and scientifically sound regulatory documents for submissions 2) Maintain awareness of changes in regulatory requirements for effective submissions 3) Ensure accuracy and quality of regulatory submissions 4) Generate and/or review regulatory documents to ensure appropriateness with regulatory requirements, agreements and regulations 5) Serve as regulatory liaison with the FDA and other regulatory agencies for assigned projects 6) Interpret and execute policies and plans affecting the department as well as the assigned projects 7) Represent (independently) the department on assigned projects 8) Make decisions outside the functional group on developmental programs 9) Translate domestic and foreign regulatory requirements 10) Provide guidance that effectively facilitates team decision-making on developmental programs 11) Liaise between pharmocovigilance CROs, sponsors, FDA and investigators for disseminating safety information and maintaining CIOMS documents Requirements 1) BS/MS in Science or health-related discipline 2) 6 – 10 years of pharmaceutical industry experience in regulatory affairs with an emphasis on clinical regulatory activities 3) Experience in all types of FDA submissions, including INDs, NDAs, CTD and supplements 4) Expertise in generating clear and concise submissions to US and non-US Health authorities 5) In-depth knowledge of US regulations, including ICH, GCP, GLP and cGMP 6) Excellent knowledge of non-US regulations 7) Proven record of establishing effective FDA interactions that result in a partnership with the Corporate Development Team 8) Exceptional productivity as a team member 9) Ability to make insightful contributions and influence decision-making 10) Excellent written and verbal communication skills, including effective negotiation techniques