Manager, Regulatory Affairs

Precision Biosciences•Durham, NC

1d•Remote

About The Position

Summary The Manager, Regulatory Affairs drives key regulatory activities, working seamlessly across functions to translate scientific, clinical, and technical insights into high-quality regulatory submissions while supporting regulatory strategy across the organization. This position is central to managing all day-to-day regulatory operations activities for the company. By supporting PBIs innovative gene editing programs for chronic Hepatitis B virus infection and Duchennes muscular dystrophy, this role directly contributes to advancing transformative therapies for patients. The Manager, Regulatory Affairs will report to the Senior Director, Regulatory Affairs. Essential Duties and Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. Regulatory Submission Execution 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 Regulatory Strategy: 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 Regulatory Operations, Quality & Compliance: 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 shiftwhile still meeting ambitious timelines with high-quality results
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

Nice To Haves

Advanced degree in regulatory or life science related discipline
Demonstrated training in regulatory affairs (e.g., coursework or RAC certification)
Experience in gene therapy, gene editing and/or rare disease
Experience leading entire complex submissions projects such as US initial IND submissions
Experience with ex-US regulatory submissions/interactions

Responsibilities

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