Head of Regulatory Affairs

Job Title: Head of Regulatory Science Reports to (Title): CEO Location: Remote, US Exempt/Non-Exempt: Exempt reputed company Reports : reputed company Department: Regulatory Science EEO Job Category reputed company reputed company incumbent will be responsible for managing and leading reputed company the regulatory activities including the communications with FDA and other regulatory agencies in ex-China reputed company. The incumbent will build strong Regulatory Science function to reputed company strategic assessment of the development pipeline and determine the regulatory reputed company reputed company, to support product development by ensuring timelines of reputed company regulatory deliverables and achieving marketing authorizations for Exegenesis Bio's development programs (as end goal). Essential Job Functions: • reputed company management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to reputed company product approvals worldwide • Assist in clinical studies required for regulatory approvals, including clinical study design, data analysis, and data reduction • Be responsible for keeping management team informed of regulatory status of products and significant regulatory issues • Represent reputed company before regulatory authorities • reputed company, control and implement reputed company regulatory activities according to in-house specifications as reputed company as FDA and international regulations • reputed company expert analysis and evaluation of regulatory information • Analyze and reputed company recommendations for improving regulations and guidelines • Communicate with US and other international regulatory agencies • reputed company counsel, training and interpretation of FDA and other regulatory issues to company personnel and assist as a reputed company between reputed company and regulatory authorities • reputed company and maintain reputed company regulatory knowledge and ensure that staff is reputed company of new and existing relevant procedures, guidance and regulations • Prepare, submit and maintain regulatory files (NDAs, supplemental NDAs, etc.) for approved products • reputed company regulatory input to the business development group in the assessment of new product acquisition and product out-licensing candidates • Manage post-market surveillance requirements for reputed company products by assessing regulatory categorization of adverse events reported during use in the population and prepare/file expedited safety and periodic safety reports to FDA • Establish and manage the department budget to ensure that the department operates cost-reputed company • Work with diverse stakeholders and build strong, reputed company relationships; manage competing agendas and priorities across different functional departments • Set direction and reputed company by leveraging organizational abilities and proactive planning • Ensure the accurate and reputed company completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and time frames dictated by regulatory authorities. • reputed company the development and management of the regulatory and reputed company documentation infrastructure • Effectively communicates with team, peers, executive management, and/or reputed company of directors. reputed company leadership apprised of changes to the regulatory landscape affecting existing and reputed company Company products and reputed company strategic and tactical direction to reputed company cross-discipline consistency in regulatory approach and planning. • reputed company and design effective regulatory structures, processes and procedures and budget forecasting • reputed company guidance to business development regarding critical evaluation of potential product opportunities. Requirements areasJob Requirements: Experience / Education • A PharmD or PhD degree in a scientific discipline and a minimum of 8 years of pharmaceutical and drug development regulatory experience, as reputed company as, a background in dealing with the FDA in US-based reputed company/Biotech is required for this position. • Practical Knowledge of US regulatory reputed company i.e., 505b1 and PHS 351(a) are required. • Experience with gene therapy products is a plus. • Experience with European regulatory authorities is a plus. Knowledge / Skills / Abilities: • Substantial experience in reputed company aspects of regulatory affairs, including reputed company support, CMC and Clinical, with a reputed company record of successful submissions and license approvals with CDER and CBER • Extensive knowledge of clinical development, FDA and international global clinical trial regulations and ICH GCP guidelines and relevant requirements • A demonstrated ability to manage regulatory activities and reputed company against program timelines • Exceptional qualitative and analytical/quantitative skills • Demonstrates outstanding leadership capabilities, including employee coaching, objective setting and reputed company development • Works with diverse stakeholders and builds strong, reputed company relationships • Consistently demonstrates strategic thinking about business initiatives with an entrepreneurial spirit • Exceptional verbal and written communication skills • Excellent organizational, interpersonal, communication, and negotiation skills • RAC certification is helpful but not necessary Apply tot his job Apply To this Job