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Director, Global Regulatory Affairs
Location
Illinois
Posted
111 days ago
Salary
$180K - $230K / year
Seniority
Lead
Job Description
Director, Global Regulatory Affairs
EVERSANA
• 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.
Job 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
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