Director/Senior Director, CMC Regulatory Affairs

Location
Durham, NC, United States
Posted
Oct 07, 2020
Ref
1411188
Hotbed
Bio NC
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Director/Senior Director, CMC Regulatory Affairs will be a key member of the Regulatory Affairs team and interface with various Cell and Gene Therapy groups in the company to provide CMC regulatory strategy and execution leadership for our cell and gene therapy development programs from discovery and pre-IND through clinical-stage development. The Director/Senior Director, CMC Regulatory Affairs will have a hands-on role within the company and will work closely with all members of the Regulatory Affairs team and individuals 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 CMC regulatory representative on project teams to provide strategy guidance, planning, and day-to-day support for 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
  • Evaluate proposed changes to manufacturing processes for CMC regulatory impact; provide strategic and operational support for decision-making regarding and execution of such changes
  • Lead CMC regulatory submission development activities including preparation and maintenance of CMC sections of INDs and BLAs, including periodic reporting activities
  • Lead 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
  • Maintain awareness of evolving regulatory requirements in the US and ROW, communicating new topics, requirements, and opportunities or risks to project teams and senior management as needed
  • 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

Qualifications

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
  • 12+ 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 significant 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 cell and/or gene therapy development programs
  • Excellent written, verbal, interpersonal, critical-thinking, and persuasion skills; ability to interact and provide guidance to individuals across the organization

Travel Requirements
  • This position may require travel up to 10%

Location
  • 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 is dedicated to improving life through its proprietary genome editing platform, ARCUS. Precision BioSciences leverages ARCUS in the development of its product candidates which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision BioSciences is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food.

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.