The Director of Regulatory Affairs, Clinical reports to the Executive Director, Regulatory Affairs, and will manage the regulatory development and approval of drug products as well as establish and maintain compliance with global regulations and requirements.PRIMARY JOB FUNCTIONSResponsible for developing global clinical regulatory strategies for development and late-stage programsLead regulatory interactions with global regulatory agencies for development and late-stage programsSupport the compliance of manufacturing (drug product and drug substance) and clinical development organizationsAuthor and review key regulatory documents required for global drug product submissions such as responses to agencies’ requests, amendments, orphan applications, expedited development applications, etc.Ensure all approved and investigational regulatory applications are current and in complianceInterpret and apply global regulations, especially in ICH regions (US, EU, CA, AU, and Asia), and keep the team informed of the global regulatory environment by reviewing updated guidanceMaintain regulatory compliance for global annual and periodic safety reportingProvide support to clinical development, commercial and business development functions as neededAuthor, edit, and review documents required for the establishment and maintenance of appropriate GxP systems within the regulatory affairs and compliance (Good Manufacturing, Good Laboratory, Good Clinical, and Good Documentation Practices)Participate in the design of CMC, non-clinical and clinical studies, review clinical protocols, pharmacy manuals, and related documents for regulatory submissionsBachelor’s degreeMust have knowledge and experience in global drug development, global regulations and guidelines and GXPsAt least 7 years of experience in drug development regulatory affairsExperience and knowledge in oncology, cardiovascular disease, neurological and metabolic diseases are strongly preferredExperience in non-clinical development, manufacturing, and Quality Assurance is a plusAbility to work collaboratively and productively in a diverse, continually changing, and team-oriented organizationAbility to work independently with internal and external stakeholders at various levelsExcellent organizational, facilitation, and communication skillsSelf-motivated and able to work from a home office environmentDemonstrated leadership capabilities and proactive problem-solverPractical knowledge of MS Word, Excel, PowerPoint, and project management softwareOTHER REQUIREMENTSThis role can be performed remotely from a home office in the US.Some long-distance travel (10%) may be required with a potential of travel occurring over weekendsFlexible approach to time management with occasional work in evenings or over weekends as required