Cardinal Health Principal Scientist, Regulatory Affairs and Product Development (Director of Regulatory Affairs) in San Diego, California
*This is an Remote position from home*
- 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
- 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.