EVERSANA

Director, Global Regulatory Affairs

EVERSANA

full-time

Posted on:

Location Type: Remote

Location: Illinois • United States

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Salary

💰 $180,000 - $230,000 per year

Job Level

Lead

About the role

  • Collaborates with client’s project team members and key decision makers to gain a complete understanding of a product and transforms that knowledge into an actionable regulatory strategy.
  • Responsible for implementing the strategy, which often entails engaging regulatory authorities, authoring submissions, and interacting with the authorities throughout the regulatory review.
  • Deliver full-service oversight and consultation to clients by providing strategic regulatory considerations and paths to market, combined with a commitment to getting products approved in various regions.
  • Collaborate with clients’ project team members and key decision makers to gain a complete understanding of the product and goals and transform that knowledge to a strategy that balances risk with potential regulatory outcomes of proposed paths in a way that clients can understand and apply in decision making.
  • Identify, propose, plan, and direct regulatory projects, transforming the regulatory strategy into executable project plans that achieve desired results and timelines.
  • Serve as a trusted intermediary with health authorities to build and maintain a positive relationship on behalf of clients.
  • Negotiate with health authorities during the development and review processes to ensure productive submission process.

Requirements

  • Bachelor’s degree in scientific discipline; advanced degree preferred.
  • Minimum of 10 years of experience in Regulatory Affairs or Regulatory Consulting in the pharmaceutical industry.
  • Proven experience in providing strategic regulatory advice to clients.
  • Applied expertise within the product development life cycles.
  • Effective verbal and written communication skills with internal and external stakeholders; strong negotiation and influencing skills.
  • Ability to explain reasoning led to conclusions in both written and oral formats.
  • Strong project management skills; knowledge and implementation of process and planning best practice; ability to manage risk and communicate it effectively.
  • Ability to manage multiple projects, priorities, and deliverables in a timely fashion.
  • Prudent and practical decision-making abilities, a team player, and can work independently without direct supervision.
  • Self-motivation, good judgment, strong follow-up, organizational, analytical, and problem-solving skills.
  • Excellent leadership, communication, and interpersonal skills.
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Remote work options
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategyregulatory submissionsproject managementrisk managementproduct development life cycleregulatory consultingstrategic regulatory advicenegotiationinfluencing
Soft Skills
communicationteam playerself-motivationgood judgmentorganizational skillsanalytical skillsproblem-solving skillsleadershipinterpersonal skillstime management
Certifications
Bachelor’s degreeadvanced degree