Cardinal Health Principal Scientist, Regulatory Affairs and Product Development in San Francisco, California

*This is an Remote position from home*

Basic Qualifications

  • 7+ years direct FDA and global regulatory affairs experience
  • Advanced technical life science degree (PhD, PharmD, MD, DVM) preferred; minimum Bachelor’s degree in a life science-related discipline
  • Regulatory Affairs Certification is preferred, but not required
  • Prior regulatory experience with biologic, oncology, combination products and devices is preferred, but not required
  • Direct experience communicating and interacting with major Health Authorities, including participating in/leading major interactions such as EOP2, pre-submission and scientific advice meetings.
  • Extensive regulatory experience specific to drug/biologic development across all product lifecycle stages
  • Experience with dossier compilation, submission and approval process in 1 or more major regions
  • Solid knowledge of FDA and global regulatory requirements and ICH guidelines
  • Demonstrated leadership and project management skills, including proven ability to effectively manage cross-functional teams
  • Experience working in a matrixed, global and multi-site environment
  • Strong written and verbal, analytical, organizational and interpersonal skills

Responsibilities

  • Develop and implement FDA global regulatory strategies, including the identification of gaps or risks, for products across a range of therapeutic areas
  • Prepare regulatory documents including Module 1, meeting requests, meeting information packages, etc.
  • Manage multiple types of local (FDA) and global regulatory applications across all phases of product development
  • Serve as the Health Authority point of contact
  • Oversee all aspects of regulatory submissions (e.g., INDs, CTAs, DSURs, etc.) including, content development and organization, coordinating cross-functional team activities, timeline maintenance, managing project financials, and ensuring compliance with applicable Health Authority requirements
  • Prepare team for and lead the conduct of milestone development meetings with Health Authorities

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.