Regulatory Affairs Consultant Needed in Seattle!

Smith Hanley Consulting Group is seeking a Regulatory Affairs Consultant for a pharmaceutical company is the Seattle area. Job Description:Regulatory Affairs Consultant (Seattle, WA): Thegeneral responsibilities will focus on supporting the development andimplementation of regulatory strategies for clinicaldevelopment and/or commercial projects. This includes responsibilityfor preparation and submission of regulatory documentation to FDA as well assupporting submissions planned for Europe, South America and Canada.Duties and Responsibilities:* Serve as the Regulatory Affairs representative on projectteams and assure the progress of projects by providing guidance and feedbackto the respective project team(s).* In coordination with project team members, develop andimplement strategies to facilitate product development and regulatoryapprovals. This includes review of applicable regulations. * Provide cross-functional direction and support in thepreparation of clinical, preclinical and/or CMC information for globalregulatory submissions. * In conjunction with Regulatory Affairs, Seattle and Europepersonnel, co-ordinate, write, compile and submit quality and timelyregulatory dossiers:* Manage the assembly, review and submission of regulatorydocumentation such as major amendments to Clinical Trial Applications ie.,INDs, CTAs and original and major amendments to registration applications,ie., NDAs, MAAs under review* Prepare and submit reports to Health Authorities (periodicreports, adverse event reports, etc).* Assist in the development of clinical trial labels andlabeling* Serve as primary FDA contact for responsible projects* Support the development of Regulatory Affairs departmentalpolicies and procedures.* Special Projects as assigned.Experience and Educational Background:* Bachelors degree in scientific discipline or equivalentrequired,* 5 years experience in the pharmaceutical industry orequivalent, * 2 plus years experience in Regulatory Affairs preferred, inpre- or post marketing activities * Demonstrated understanding of regulations and guidelinesgoverning drug development including ability to apply these to strategicdrug development.* Background in Pharmacy and/or Oncology preferred.Knowledge, Skills, and Abilities:* Demonstrated effective interpersonal skills* Excellent writing and communication skills* Ability to interact successfully with peers and across alllevels of management* Attention to detail* Computer skills in Word and MS Office, preferred If you possess the necessary qualifications for this position and are interested in applying for this employment opportunity, please email your updated Word version resume to Lynn Rodriguez at lrodriguez@smithhanley.com . Education:Bachelor's Degree