Associate Director, Regulatory Affairs

Regulatory Affairs PositionThis position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of Company's quality, preclinical, and clinical drug development programs, policies, and procedures, so that development teams are able to meet all objectives within specified timelines and the necessary state of compliance is maintained relative to all regulatory commitments/requirements.Responsibilities:Act as liaison between company and FDA and other health authorities for assigned programsDevelop regulatory strategies for assigned programs, in order to support Company's development and marketing objectivesManagement of regulatory activities associated with Company development programsParticipate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goalsProvide guidance to multidisciplinary teams on the content, format, style and architecture of an Investigational New Drug (IND) application or CTA for ex-US studiesEdit or manage the editing of scientific sections of regulatory documentation against the regulatory requirementsAssist with the writing, review and preparation of an IND applicationManage the organization, preparation and review of IND amendments, annual reports and other regulatory documents and correspondencePerform/manage critical analyses of data (clinical, preclinical and manufacturing), independently developing interpretations and conclusionsPerform reviews of clinical protocols and study reports to focus attention on deficient/missing items/explanationsAccountable for ensuring the completeness and accuracy of all regulatory submissionsSupervisory responsibility for the planning, preparation and submission of regulatory documentationManagement of the planning, preparation and submission process for licensing applicationsProvide guidance/instruction to multidisciplinary teams on the content, format, style architecture and timing of a Biologics Licensing Application (BLA) or MAA and the subsequent regulatory review processAssist with the scientific writing and review of a BLA and evaluate conformance with the regulatory requirementsContinually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programsProvide training on applicable requirements for scientific staff as requiredRequirements:Requires an advanced technical degree in life sciencesExpert knowledge of regional health authority regulations and advanced knowledge of global regulationsDemonstrated interactions with local health authoritiesExcellent communication skills (verbal and written) and strong analytical skillsDemonstrated leadership and project management skills, including cross-functional communicationEducation: Ph.D., PharmD, or MDAt least 5+ years of RA experience and biomedical researchBenefits:Medical, Dental, Vision all Start Day One401k @.50 on the dollar up to 10%, Vested in 4 YearsStock OptionsRestricted Shares of StockOutstanding Relocation PackageCost of Living Adjustments