Job Number: 20016214

Location: Overland Park, KS

Date Posted: 7-22-2017

Job Title: Director, Global Regulatory Affairs

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Position Summary

The Director of Global Regulatory Affairs will lead a dispersed team of full-service strategic product development and global regulatory affairs consulting teams that enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. The Director will have experience interacting with foreign and domestic regulatory bodies, passion for leading people, a demonstrated record growing market share and relevant academic credentials and scientific knowledge.

The business has a diverse portfolio of projects spanning large, publically traded organizations to venture/private equity backed drug and medical device entities across a range of therapeutic categories and formulation varieties.Within the business,

Regulatory Sciences is a division of Specialty Solutions within Cardinal Health’s Pharmaceutical Segment.

Position Accountabilities

  • Lead regulatory strategy, oversight and guidance and effectively leading cross functional teams
  • Interact effectively with the FDA and other foreign regulatory bodies.
  • Provide leadership for a diverse and complex organization
  • Communicate effectively with external agencies and build upon Cardinal’s reputation for integrity and ethical behavior
  • Direct and manage the preparation, submission and maintenance of INDs, NDAs and other regulatory applications
  • Assist in clinical studies required for regulatory approvals, including clinical study design, data analysis, and data reduction
  • Proactively inform leadership team of regulatory status of products and significant regulatory issues
  • Provide counsel, training and interpretation of FDA and other regulatory issues to company personnel and act as a liaison between the company and regulatory authorities
  • Author, review and critique documents included in regulatory applications for domestic and international authorities
  • Obtain and disseminate information regarding current activities, trends and changes in the regulatory environment
  • Host FDA/third party regulatory audits and ensure follow up on findings/observations issued including CAPAs, as needed
  • Serve as a principal spokesperson on significant matters related to the position’s oversight
  • Appropriately manage organizational and project budgets
  • Strategic mindset and approach coupled with a hands-on operating style
  • Participate, with executive leadership, in the development and implementation of strategic business plans, decisions and recommendations
  • Remain assessable and coach employees when needed; maintain high levels of work and employee accountability
  • Maintain and fully utilize broad external network to enhance business opportunities and grow market share; strong negotiation skills
  • Strong focus on broad spectrum of Cardinal Health sales opportunities including new business directions
  • Drive a creative and focused strategy, leading to the effective management and growth of Cardinal Health’s Regulatory Sciences business; encourage informed risk-taking and act as a catalyst for innovation
  • Identify emerging technologies and instrumentation and make appropriate recommendations for business application
  • Demonstrated ability breaking down silos and rebuilding team across an organization
  • Ability to effectively manage highly experienced consultants while nurturing and mentoring those less experienced

Position Qualifications

  • 15 years of experience in the pharmaceutical industry; 10 years of relevant experience within Regulatory Affairs
  • BS/BA in a relevant field of study required; MS or PharmD/PhD preferred
  • Proficient in the delivery and conduct of all Regulatory Affairs activities including, but not limited to: submissions, publishing, review and oversight
  • Thorough understanding of regulations of ICH, FDA and EMA.
  • Knowledge of GLP, GMP and GCP regulations
  • Ability to work well under pressure and adhere to deadlines
  • Proven ability to manage and grow productive teams
  • Excellent written and verbal communication skills
  • Ability to travel up to 40 percent

Position Attributes/Characteristics

  • Entrepreneurial
  • Dedicated
  • High attention to detail
  • Motivated
  • Creative
  • Authentic
  • Servant leader
  • Clear, concise communicator

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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