My client is a successful, global CRO supporting leading pharmaceutical and biotech companies across the Untied States. They are seeking a Technical Regulatory Specialist to provide oversight to the team responsible for compilation, preparation, and review of all Regulatory Submissions. This role would be remote based with frequent travel to the company office in Canton, Michigan required.
• Provides oversight for the team(s) responsible for global submissions including the compilation, preparation, review and submission to Health Authorities.
• Assists in strategic planning activities and translation of strategic decisions into operational plans related to all areas of regulatory operations.
• Provides oversight to ensure processes are in place for the publishing of regulatory submissions according to ICH electronic Common Technical Document (eCTD) format and submission ready standards.
• Identifies resources and provides guidance for process updates due to changing regulations that impact submission strategies and technologies.
• 10+ years of experience in pharmaceutical or CRO industry required.
• Experience leading pre- and post-approval marketing applications (both NDA and MAA).
• Strong knowledge of current and upcoming Health Authority regulations, particularly related to data standards and exchange.
• Working knowledge of ex-US submissions (CTA and MAA), including EMA, Health Canada, and Australia.
• Manage cross-functional teams and progress partnerships in support of goals that affect colleagues in all regions.
This role is being handled by Gabrielle at Meet, for more information and a confidential discussion please reach out via email: gabrielle@peoplewithchemistry or phone: 646.569.9081.