Head of Regulatory Affairs

Job Summary:

This position is responsible for managing and leading all regulatory activities, including communications with FDA and other regulatory agencies in ex-China regions. The incumbent will build a strong Regulatory Science function to provide strategic assessment of the development pipeline and determine the regulatory path forward, to support product development by ensuring timelines of all regulatory deliverables and achieving marketing authorizations for Exegenesis Bio's development programs.

Key Responsibilities:

• Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain 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 the company before regulatory authorities
• Direct, control and implement all regulatory activities according to in-house specifications as well as FDA and international regulations
• Provide expert analysis and evaluation of regulatory information
• Analyze and make recommendations for improving regulations and guidelines
• Communicate with US and other international regulatory agencies
• Provide counsel, training and interpretation of FDA and other regulatory issues to company personnel and assist as a liaison between the company and regulatory authorities
• Develop and maintain current regulatory knowledge and ensure that staff is aware of new and existing relevant procedures, guidance and regulations
• Prepare, submit and maintain regulatory files (NDAs, supplemental NDAs, etc.) for approved products
• Provide 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 commercial 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-efficiently
• Work with diverse stakeholders and build strong, collaborative relationships; manage competing agendas and priorities across different functional departments
• Set direction and focus by leveraging organizational abilities and proactive planning
• Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and time frames dictated by regulatory authorities.
• Oversee the development and management of the regulatory and quality documentation infrastructure
• Effectively communicates with team, peers, executive management, and/or board of directors. Keep company leadership apprised of changes to the regulatory landscape affecting existing and future Company products and provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
• Develop and design effective regulatory structures, processes and procedures and budget forecasting
• Provide guidance to business development regarding critical evaluation of potential product opportunities.

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 well as, a background in dealing with the FDA in US-based Pharma/Biotech is required for this position.
• Practical Knowledge of US regulatory pathways 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 all aspects of regulatory affairs, including Commercial support, CMC and Clinical, with a track 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 deliver against program timelines
• Exceptional qualitative and analytical/quantitative skills
• Demonstrates outstanding leadership capabilities, including employee coaching, objective setting and professional development
• Works with diverse stakeholders and builds strong, collaborative 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