Director, Global Regulatory Affairs

The Director, Global Regulatory Affairs will support multiple pharmaceutical companies as a Regulatory Affairs Leader and Subject Matter Expert. Key contributions of this role include developing and implementing regulatory strategies, overseeing all aspects of programs and projects, and lead Health Authority meetings and interactions for our clients, among others.

Accountabilities

  • Leadership, development, and execution of global regulatory strategies across a broad range of drug, device, biologic, and combination product modalities and therapeutic areas
  • Lead cross-functional internal and external teams, including executive level client teams, and provide strategic insight, recommendations, and business-oriented regulatory opinions, and align teams to each, as applicable
  • Program and project oversight and management, including budgets, timelines, and resources
  • Effectively, proactively, and respectfully communicate and engage program and project teams to achieve goals and milestones
  • Oversee, contribute to, and/or prepare all or part of regulatory submissions including but not limited to INDs, IDEs, IMPDs, CTAs, NDAs, BLAs, 510Ks, PMAs, meeting packages, and those for expedited programs, and ensure they meet regulatory requirements, industry standards, and timelines
  • Perform and prepare due diligence assessments that may include risk mitigation strategies  
  • Prepare teams for and lead meetings, including face-to-face, with Health Authorities
  • Serve as the Health Authority point of contact, including as US Agent for ex-US clients
  • Build, manage, and maintain successful partnerships with clients
  • Mentor and share knowledge with other CHRS Consultants as needed to help build, establish, and maintain a global regulatory consulting presence
  • Continually build upon and maintain knowledge base of global regulatory landscape, regulations, and guidance
  • Contribute to business development activities, including initial client meetings, and provide input on proposals and contracts
  • Review and approve weekly internal timecards and monthly project invoices
  • Continually demonstrate Cardinal Health Values and Leadership Essentials

Qualifications

  • 10+ years (with advanced degree preferred) or 15+ years (with Bachelor’s degree in a life sciences discipline preferred) regulatory affairs experience with increasing leadership in the pharmaceutical/biotechnology industry and/or in a regulatory affairs consulting capacity or a combination thereof
  • Advanced degree (DRSc, PhD, PharmD) preferred but not required;
  • Regulatory Affairs Certification preferred, but not required
  • Experience communicating and interacting directly with major Health Authorities for PIND, IND, EOP2, pre-marketing application, and/or scientific advice meetings in more than 1 major region
  • Experience with and oversight of marketing application preparation, submission, and approval process in more than 1 major region
  • Demonstrated experience leading face-to-face meetings with FDA and/or other Health Authorities
  • Solid knowledge of FDA, EMA, and other global regulations and ICH guidelines
  • Expert in product development and experience in early to late stage as well as post-approval phases
  • Demonstrated leadership and program/project management skills, including proven ability to effectively manage cross-functional teams
  • Regulatory affairs experience in advanced or gene therapies and/or devices a plus but not required
  • Experience working in a matrixed, global, and multi-site environment
  • Strong written and verbal, analytical, organizational, and interpersonal skills
  • Ability to manage multiple ongoing projects, each at various stages of development, with minimal if any supervision
  • Demonstrated ability to effectively and positively influence stakeholders
  • Strong attention to detail and right-the-first-time approach
  • This is a remote work from home position
  • A Covid-19 vaccination is required in order to be employed in this position. This includes either:
    • 2 doses of the Moderna or Pfizer vaccine
    • 1 dose of the Johnson & Johnson vaccine

Anticipated salary range: $175,000-$215,000

Bonus eligible: Yes

Long term incentive eligible: Yes

Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD

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.