The Senior Associate, Regulatory Affairs plays a critical role in organizing, training, and leading regulatory associate staff in handling all day-to-day regulatory operations activities for the company. The Senior Associate, Regulatory Affairs also leads or 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. Finally, the Senior Associate, Regulatory Affairs serves as an important consultative resource for junior Regulatory Affairs staff as well as staff in other segments of the company.
Essential Dutiesand 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.
Independently oversees routine regulatory activities for individual project teams to ensure alignment and compliance with local and regional registration requirements as well as with company policies
Develops and implements strategies for timely submission and approval of routine and substantive regulatory submissions including initial trial applications (e.g. IND, CTA, CTX) and marketing applications, with support and guidance from senior regulatory management as needed and primarily for complex/late-stage activities
Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies
Guides regulatory tactics within matrix-managed project teams to ensure compliant development programs
Leads and guides content generation, with input from other functions, to ensure timely and successful compilation of complex multidisciplinary content for regulatory submissions
Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance
Monitors and improves tracking/control systems to ensure efficient operations across disciplines within the company
Keeps abreast of regulatory procedures and evaluates important changes in the regulatory landscape for regulatory team awareness
Directs interaction with regulatory agencies on defined matters
Completes all assigned tasks independently without significant day-to-day guidance or support
Provides counsel to and manages junior direct reports
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
Bachelor’s Degree in Biological Sciences and demonstrated training in regulatory affairs (e.g., coursework or RAC certification); advanced degree in health sciences strongly preferred
4+ 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 GxP
Understanding of electronic publishing processes and best practices
Diverse experience authoring, reviewing, and editing documents for regulatory submission such as INDs, IMPD, CTAs, BLAs, and MAAs, as well as related health authority interactions
Ability to support multiple projects and to prioritize work independently
Ability to lead teams of subject matter experts to develop documents collaboratively
Strong written and verbal communication, negotiation, leadership, and interpersonal skills
Comprehensive understanding of IND filing requirements
Experience leading entire complex submissions projects such as US initial IND submissions
Specific experience authoring and maintaining Module 3 (CMC) sections of US INDs
Experience with BLA filing and/or ex-US regulatory activities
Direct experience performing electronic publishing for regulatory submissions
Familiarity with common regulatory tools/software such as eCTD viewers, Regulatory Information Management Systems, electronic signatures and certificates, etc.
Travel may be required to attend conferences, inspect or monitor vendors, and support Company business development activities. Travel time is expected to be less than 10% on average.
The Senior Associate, Regulatory Affairs will be expected to travel to all applicable locations when needed
This is a primarily office-based position associated with the main headquarters in downtown Durham, NC. For the time being, this role will be able to function remotely in accordance with company safety guidelines throughout the duration of the pandemic 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 allogeneic CAR T and in vivo gene correction therapies for cancer and 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.
Internal Number: n/a
About Precision BioSciences
Precision BioSciences, Inc. is dedicated to improving life by developing advanced tools to edit DNA with a uniquely specific approach. Our proprietary method relies on a single small enzyme, ARC Nuclease, which combines cutting with sequence recognition and can be redesigned to find and edit new target sites across the genome. This simple, powerful gene editing solution allows us to create products that solve – not just treat, but solve – significant problems in oncology, genetic disease, agriculture, and beyond. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented, committed people who are excited to be a part of the medical and scientific breakthroughs enabled by Precision’s next generation gene editing technology. For additional information, please visit www. precisionbiosciences.com