Manager, Regulatory Affairs

Role Overview

• Drives timely submission and approval of routine and substantive regulatory submissions including initial trial applications (e.g. IND, CTA) and marketing applications, with support and guidance from senior regulatory management as needed
• Coordinates and prepares document packages for regulatory submissions to ensure alignment and compliance with applicable regulations and guidelines
• Leads and guides content generation, with input from other functions and external vendors, to ensure timely and successful compilation of complex multidisciplinary content for regulatory submissions
• Manages relationships cross functionally with internal teams, including program teams, CMC, Clinical, Translational, Quality and external partners to execute routine regulatory activities
• Ensures submissions are compliant with local and regional registration requirements as well as with company policies
• Performs regulatory research to keep abreast of regulatory procedures, FDA/EMA/ICH guidance and policy trends and provides guidance to internal teams to ensure compliance
• Supports Senior Director, Regulatory Affairs with FDA (or other health authority) meeting strategy and execution, briefing package and questions development, agency correspondence and alignment on regulatory expectations
• Partners closely with Senior Director, Regulatory Affairs to support regulatory strategy, long-range regulatory planning, and other regulatory duties, as assigned
• Maintains and improves tracking and archival systems to ensure efficient and compliant operations for regulatory submission preparation and archival
• Develops new regulatory operations procedures and best practices
• Coordinates external regulatory operations activities with outside partners (i.e. publisher, external consultants)
• Supports the preparation for regulatory authority interactions, meetings and inspections

Requirements

• Bachelors Degree in life science related discipline and 7+ years of regulatory experience in the Pharmaceutical industry (preferably Biotech), or equivalent combination of education and experience
• Demonstrated ability to thrive in a fast-paced environment, managing multiple projects simultaneously and adapting quickly as priorities shift
• Diverse experience authoring, reviewing, and editing documents for regulatory submission such as INDs, IMPD, CTAs, BLAs, and MAAs, as well as supporting related health authority interactions (previous experience with CBER a plus)
• Strong knowledge of regulations and guidelines that govern clinical research, including but not limited to FDA regulations and ICH guidelines
• Proficiency in reviewing electronic submissions prior to submission by third-party publisher
• Familiarity with common regulatory tools/software such as eCTD viewers, Regulatory Information Management Systems, electronic signatures and certificates, etc.
• Proven leadership of cross-functional teams of subject matter experts with agility and focus, driving rapid, collaborative document development even under tight deadlines
• Excellent written and verbal communication, problem solving, collaboration, and project management skills
• Advanced degree in regulatory or life science related discipline (preferred)
• Demonstrated training in regulatory affairs (e.g., coursework or RAC certification) (preferred)
• Experience in gene therapy, gene editing and/or rare disease (preferred)
• Experience leading entire complex submissions projects such as US initial IND submissions (preferred)
• Experience with ex-US regulatory submissions/interactions (preferred)

Benefits

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position
• Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission.
• Equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.
• Compliance with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.