Director/Sr. Director
Regulatory Affairs CMC
Posted on 11/8/2023
United States
Experience Level
Desired Skills
Google Cloud Platform
  • A minimum of a Bachelors Degree required (life sciences disciplines strongly preferred) with approximately ten years of experience in the biotechnology or pharmaceutical industries in regulatory affairs or related functions in drug/biologics development/manufacturing
  • Gene Therapy CMC Experience required
  • Great attention to detail, ability to work on multiple projects with tight deadlines, and ability to work independently
  • Demonstrated experience leading eCTD formatted submissions, e.g., INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements, for drugs and/or biologics
  • Has successfully led responses to health authorities or other critical submissions while maintaining agreed timelines
  • Ability to communicate regulatory expectations that pertain to the drug development process, FDA/EMA/global guidance and regulations, to cross-functional teams
  • Excellent oral and written communication and time management skills are essential
  • Demonstrated ability to work effectively with and/or lead cross-functional team activities, e.g., research, clinical, and TDO teams
  • Ability to develop regulatory plans and strategies while proactively identifying risks
  • Ability to work on multiple tasks with strong attention to detail to meet company objectives
  • Knowledge of ICH, GCP, GMP, and other relevant global guidelines
  • Excellent computer skills, e.g., MS Word, Excel, PowerPoint, and electronic document management software/systems
  • Oversee the development and implementation of robust CMC regulatory strategies for all gene therapy development programs, anticipating phase-appropriate and future commercial requirements in close collaboration with Technical Operations and Quality colleagues
  • Lead discussions with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally to refine CMC development strategies
  • Oversee planning, preparation, and submission of high-quality regulatory CMC dossiers based on prior knowledge and current environment of the GTx landscape
  • Serve as regulatory voice and provide CMC guidance to internal teams and lead cross-functional teams to prepare briefing packages, Module 3 and 2.3 sections for INDs, and equivalent IMPD sections for CTAs
  • Assess the regulatory impact of proposed manufacturing process changes
  • Track regulatory CMC commitments; manage ongoing regulatory submissions and future reporting requirements, including annual reports
  • Effectively build, maintain, and motivate a high-performing regulatory CMC team, including hiring, developing, coaching, and mentoring diverse, talented, and driven staff
  • Actively participate in building an outstanding regulatory team, leveraging operational excellence to implement innovative regulatory strategies efficiently
  • Maintain knowledge of the global regulatory CMC environment and applicable regulations and guidelines. Lead reg-CMC intelligence activities
  • Support Quality and CMC team during GMP inspections
  • Participate in external trade organizations, related industry conferences, and opportunities to engage with health authorities to be at the forefront of evolving regulations
Desired Qualifications
  • Experience in gene therapy
  • Experience with eCTD formatted submissions
  • Knowledge of FDA/EMA/global guidance and regulations
  • Experience working with cross-functional teams
  • Knowledge of ICH, GCP, GMP, and other relevant global guidelines