SUMMARY

The Associate Director, Regulatory Operations will be responsible for handling all day-to-day regulatory operations activities for the company, including managing the timely preparation and submission of regulatory filings to the FDA, MHRA, and other international agencies. The Associate Director, Regulatory Operations also supports complex strategic regulatory activities, coordinating across functions as needed to assemble or support assembly of information from relevant disciplines to produce complete, high-quality regulatory submissions. This role is critical to the success of PBI’s gene editing programs for patients with chronic Hepatitis B virus infection and Duchenne’s muscular dystrophy. The Associate Director, Regulatory Operations brings a passion for scientific innovation and translational impact.
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.

• Lead timely preparation, publication, and submission of routine and substantive regulatory submissions including initial trial applications (e.g. IND, CTA, CTX), amendments, and marketing applications, with support and guidance from senior regulatory management
• Ensure compliance of submissions with current regulatory requirements as well as with company policies
• Independently oversee and maintain routine regulatory operations, including management of submission tracking and archival systems, development of regulatory operations procedures and best practices
• Collaborate with multi-disciplinary teams including Nonclinical, CMC, Clinical and Quality to ensure timely and successful compilation of complex multidisciplinary content for regulatory submissions
• Coordinate external regulatory operations activities with consultants and partners
• Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance
• Prepare for regulatory authority interactions, meetings and inspections
• Keep abreast of regulatory procedures and evaluate important changes in the regulatory landscape to ensure compliance as standards continuously evolve

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 Biological Sciences and demonstrated training in regulatory affairs (e.g., coursework or RAC certification); and 8+ years of regulatory experience in the Pharmaceutical industry (preferably Biotech), or equivalent combination of education and experience
• Strong knowledge of regulations and guidelines that govern clinical research, including but not limited to FDA regulations and ICH guidelines
• Diverse experience preparing, reviewing, and submitting document packages to health authorities such as INDs, IMPD, CTAs, BLAs, and MAAs, as well as supporting related health authority interactions
• Strong understanding of electronic publishing processes (eCTD) and best practices
• Familiarity with common regulatory tools/software such as eCTD viewers, Regulatory Information Management Systems, electronic signatures and certificates, etc.
• Ability to support multiple projects and to prioritize work independently and according to set deadlines
• Ability to lead cross-functional teams of subject matter experts to develop documents collaboratively in a timely manner
• Strong attention to detail and commitment to quality standards
• Excellent written and verbal communication, problem-solving, collaboration, and project managements skills

Preferred:

• Advanced degree in Biological Sciences
• Experience working on clinical stage gene therapy or biologics programs
• Comprehensive understanding of IND filing requirements
• Experience with submissions to ex-US health authorities, e.g. EMA, MHRA
• Direct experience performing electronic publishing for regulatory submissions
• Specific experience authoring and maintaining Module 3 (CMC) sections of US INDs a plus

LOCATION & TRAVEL REQUIREMENTS

This is a primarily office-based position associated with the main headquarters in downtown Durham, NC. This role will be able to function remotely, with some (up to 25%) travel to our office expected.
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

• Lead timely preparation, publication, and submission of routine and substantive regulatory submissions including initial trial applications (e.g. IND, CTA, CTX), amendments, and marketing applications, with support and guidance from senior regulatory management
• Ensure compliance of submissions with current regulatory requirements as well as with company policies
• Independently oversee and maintain routine regulatory operations, including management of submission tracking and archival systems, development of regulatory operations procedures and best practices
• Collaborate with multi-disciplinary teams including Nonclinical, CMC, Clinical and Quality to ensure timely and successful compilation of complex multidisciplinary content for regulatory submissions
• Coordinate external regulatory operations activities with consultants and partners
• Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance
• Prepare for regulatory authority interactions, meetings and inspections
• Keep abreast of regulatory procedures and evaluate important changes in the regulatory landscape to ensure compliance as standards continuously evolv