Head of Regulatory Affairs

Job Description

Job Title: Head of Regulatory Science

Reports to (Title): CEO

Location: Remote, US

Exempt/Non-Exempt: Exempt

Direct Reports : Yes

Department: Regulatory Science

EEO Job Category Professional

Job Summary: This incumbent will be responsible for managing and leading all the regulatory activities including the communications with FDA and other regulatory agencies in ex-China regions. The incumbent will build 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 (as end goal).

Essential Job Functions:

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

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 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

Full-time

Fully remote