Regulatory Lead, CMC (Associate Director)
The CMC Regulatory Lead will be a key member of the Regulatory Affairs team and interface with various Cell and Gene Therapy groups in the company to provide leadership and guidance for a wide range of topics related to CMC regulatory affairs for our cell and gene therapy development programs. The CMC Regulatory Lead will work closely with all members of the Regulatory Affairs team and with individuals involved in CMC Development, CMC Technical Operations, Quality Assurance, and Quality Control at Precision BioSciences to ensure compliance with US, EU, and ICH requirements.
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.
- Provide company-wide CMC regulatory expertise for projects ranging from early pre-clinical through late-stage work such as preparation of commercial registration submissions and support for preapproval inspections
- Serve as regulatory representative on project teams to provide planning and day-to-day guidance on CMC regulatory topics
- Identify risks and develop mitigation or contingency plans for project-related CMC regulatory issues
- Lead development of phase-appropriate CMC regulatory strategy for cell and gene therapy products in Precisions portfolio
- Lead CMC regulatory submission development activities including CMC sections of INDs and BLAs
- Lead or support and participate in CMC-focused regulatory authority meetings
- Mentor junior regulatory staff by providing tactical and strategic guidance to team members on diverse regulatory topics, including with a specific emphasis on CMC regulatory
- Act as CMC Regulatory Subject Matter Expert during audits and inspections, both internal and external
- Manage scope of work, budget, and timeline for outsourced CMC regulatory activities such as focused engagements with specialist consultants
- Provide CMC regulatory expertise for business development including due diligence activities
- Represent the company at conferences and in business development meetings
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
- Advanced degree in the life sciences or PharmD, or equivalent demonstration of capabilities and job-specific training; PhD preferred
- 10+ years experience in regulated product development, focusing on CMC regulatory topics ranging and supporting the manufacturing teams, from pre-formulation through to late-stage work, including supporting pre-approval inspections and similar regulatory interactions
- Extensive experience with US regulatory submissions and regulatory interactions focusing on CMC topics; Ex-US experience a plus
- Experience leading CMC teams in the preparation of INDs, substantial IND amendments, briefing books, and BLA submissions
- Proven ability to establish productive working relationships with regulators
- Ability to foster strong relationships, motivate others, and build highly effective teams
- Substantial working familiarity with all other disciplines of integrated product development programs (nonclinical, clinical pharmacology, clinical, statistical, regulatory, etc.); excellent time-management, organizational, and project-management skills
- Experience with CMC challenges and topics specific to biologics required; experience with cell and/or gene therapy development programs strongly preferred
- Excellent written, verbal, interpersonal, critical-thinking, and persuasion skills; ability to interact and provide guidance to individuals across the organization
- This position may require travel up to 10%
- 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. 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 Precisions next generation gene editing technology. For additional information, please visit www. precisionbiosciences.com
Precision BioSciences provides 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.