Regulatory Affairs Manager (NPD)

What Regulatory Affairs contributes to Cardinal Health

Regulatory provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This function applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting.

Regulatory Affairs plans, coordinates and implements regulatory strategies for products that require government approval. This job family proactively identifies regulatory requirements and risks for products and develops plans for product development programs and regulatory submissions.

Accountabilities

  • The Regulatory Affairs Manager (NPD) will lead a team of regulatory professionals responsible for the support of new product development (NPD) projects and initiatives at Cardinal Health. Specific activities include but are not limited to:
  • Deliver innovative and favorable regulatory strategies that produce timely and predictable worldwide regulatory approvals
  • Lead a team of Regulatory Affairs professionals in the management of new product development projects to establish and integrate regulatory submissions strategy into project activities
  • Coach team members on the preparation of high-quality submissions (i.e., Pre-Sub, 510(k)s, PMAs, EU Technical Documentation Files and International STEDs)
  • Maintain proficiency on global regulatory requirements. Evaluate proposed regulatory requirements and their impact on medical devices submissions
  • Develop and maintain rapport with reviewers within regulatory agencies, such as US FDA, and Notified Bodies
  • Develop, maintain, and improve regulatory metrics related to regulatory submissions quality, project phases and submissions turnaround times to drive better predictability of project timelines and more favorable outcomes
  • Advise cross-functional product development teams on testing and claims substantiation requirements in support of successful market launches  
  • Plans and implement regulatory policies, procedures, systems, practices, and strategy related to new product development and initial product launches, as required
  • Contribute to team resourcing and project timeline planning

Qualifications:

  • BA, BS or equivalent experience in related field Advance Degree may be required
  • 6-10 years Regulatory Affairs experience focused on new product development and global regulatory strategy development required
  • Majority of Regulatory Affairs experience in Medical Device industry preferred
  • A Covid-19 vaccination is required in order to be employed in this position. This includes either: 
    o    2 doses of the Moderna or Pfizer vaccine
    o    1 dose of the Johnson & Johnson vaccine

What is expected of you and others at this level

  • Manages department operations and supervises professional employees, frontline supervisors and/or business support staff
  • Participates in the development of policies and procedures to achieve specific goals
  • Ensures employees operate within guidelines
  • Decisions have a short term impact on work processes, outcomes, and customers
  • Interacts with subordinates, peer customers and suppliers at various management levels may interact with senior management
  • Interactions normally involves resolution of issues related to operations and/or projects
  • Gains consensus from various parties involved

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.