Job Description

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 PBI’s innovative gene editing programs for chronic Hepatitis B virus infection and Duchenne’s 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

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Required:

• Bachelor’s 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—while 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

Preferred:

• 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

Travel Requirements

Minimal travel may be required to attend conferences or to our office if this position is remote.

Location

This is an office-based position associated with the main headquarters in Durham, NC. This role will be able to function remotely in accordance with company guidelines but is subject to change as needed.

Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. This isn’t just a statement supporting the products that we’re developing – it’s a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing in vivo gene correction therapies for genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com

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. We provide 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. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Job Tags

Similar Jobs