Precision Medicine Group

Compensation

Full Description

Job Description: • Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications • Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards • Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers • Works within a project team, and where necessary, leads project for the region or globally • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated • Assist in development of Regulatory Affairs Specialists and other operational area staff, as required • Provide input, as required, into regulatory strategy and timeline development for new study opportunities • Assists in establishing company standards to ensure the highest quality of submitted information • Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions • Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval • Provides ICH GCP guidance, advice and training to internal and external clients • Serve as representative of Global Regulatory Affairs at business development meetings Requirements: • Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline • Computer literacy (MS Office/ Office 365) • Fluent in English • 5 + years or more relevant regulatory affairs experience • Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones • Specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions • Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy • Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied • Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development • Availability for domestic and international travel including overnight stays Benefits: • health insurance • retirement savings benefits • life insurance • disability benefits • parental leave • paid time off for sick leave and vacation • discretionary annual bonus