Director, Principal Scientist Regulatory Affairs – Advanced Therapies at Cardinal Health

Remote
Cardinal Health

Director, Principal Scientist Regulatory Affairs – Advanced Therapies (remote)

Location: USA-

For over four decades, our industry\-trained regulatory consultants have provided expertise and guidance to help pharmaceutical, biotechnology, and medical device companies get their products to market\. Our regulatory and product development strategies are designed to reduce the risk of failure and increase financial returns on research investments\. We provide efficient scientific and regulatory consulting services throughout the full product lifecycle\.

The Director level Principal Scientist will support multiple clients as a Regulatory Affairs Subject Matter Expert\. They will develop and implement regulatory strategies, oversee all aspects of regulatory submission development, and lead Health Authority interactions for our clients\.

Accountabilities

  • Develop and implement regulatory strategies, including the identification of gaps or risks, for biologic and drug products across a range of therapeutic areas, including cell and gene advanced therapies
  • Prepare regulatory documents including Module 1, meeting requests, meeting information packages, etc\.
  • Manage multiple types of Health Authority applications \(e\.g\. IND, BLA\) across all phases of product development
  • Serve as the Health Authority point of contact \(e\.g\. US Agent\)
  • Oversee all aspects of regulatory submissions \(e\.g\., INDs, CTAs, BLA, etc\.\) including content development and organization, coordination of cross\-functional team activities, timeline maintenance, management of project financials, and ensuring of compliance with applicable Health Authority requirements
  • Prepare teams for and lead the conduct of milestone development meetings with Health Authorities
  • Interact with cross\-discipline client teams, including senior executive teams, to contribute strategic advice, insight and business\-oriented regulatory opinions

Qualifications

  • 10\ years regulatory affairs experience
  • Advanced technical life science degree \(PhD, PharmD, MD, DVM\) preferred; minimum Bachelor’s degree in a life science\-related discipline\. Preferably in genetics, biochemistry, or immunology
  • Prior regulatory experience with biologic products, including Advanced Therapies \(e\.g\., cellular and gene therapies\) required
  • Regulatory Affairs Certification is preferred, but not required
  • Direct experience communicating and interacting with major Health Authorities, including participating in/leading major interactions such as INTERACT, PIND, EOP2, and scientific advice meetings
  • Extensive regulatory experience across all product lifecycle stages
  • Experience with dossier compilation \(e\.g\. BLA\), submission and approval process in 1 or more major regions
  • Solid knowledge of FDA, EMA and other global regulations/regulatory requirements and ICH guidelines
  • Demonstrated leadership and program/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

This is a remote work from home position

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\.

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