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Regulatory Affairs Sr. Manager/Associate Director

Company: Arrowhead Pharmaceuticals
Location: Pasadena
Posted on: March 27, 2020

Job Description:

The Position--The Global Regulatory Lead (GRL) is responsible for facilitating global drug product development and global registration by contributing to the development and execution of regulatory strategies and effective regulatory agency interactions. The GRL will be responsible for providing day to day regulatory support to the project team and regulatory team management.ResponsibilitiesDevelop effective regulatory strategies for global submissions pertaining to specific projects to expedite the development, filing, and regulatory approval for new development productsParticipate in product development teams to support execution of regulatory strategy ensuring regulatory deliverables are met within agreed upon timelines and provide appropriate advice and support to ensure compliance with all regulatory requirementsThe GRL will also be the primary day-to-day liaison with the Program, Clinical, Safety and CMC team responsible for regulatory submissions and contribute to the development of scientific responses to Agency submissions and responses to questionsCollaborate with CRO's / partners to support clinical trial approval and site initiationOversees, prepare and manage various submissions and scientific responses to regulatory authority questions ensuring adherence to national and international regulations and standards (e.g. FDA, Health Canada, European Union and Asia)Interact with regulatory authorities regarding assigned projects as requiredMaintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategiesRequired: Bachelor's degree in a Science disciplineMinimum of 7 years of relevant experience in pharmaceutical drug development with at least 4 years in regulatory affairs in the development of novel molecular entitiesDemonstrable experience in successfully developing and managing regulatory submissions, review and preparation of scientific/technical/clinical responses to agency questionsGood understanding of pharmaceutical development, clinical research and the regulatory environmentExceptional organizational skills, ability to multi-task and be detail orientedStrong interpersonal and communication (both oral and written)Works well within diverse groups to achieve common goals as demonstrated through support for team ownership of projects to ensure resultsAbility to maintain highest degree of professionalism, integrity and diplomacyStrong problem solving skills and ability to deal with changing prioritiesExcellent project management skillsProficient in pertinent software & toolsTechnical writing experiencePreferred: PhD or Pharm.D.Prior experience with the preparation of CTA/IND sections for regulatory submissions, as well as knowledgeable of ICH and FDA guidelines relevant to nonclinical, clinical and CMC aspects of product developmentKnowledgeable in industry trends for study reports and dossier preparation (e.g., IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD)

Keywords: Arrowhead Pharmaceuticals, Pasadena , Regulatory Affairs Sr. Manager/Associate Director, Executive , Pasadena, California

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