THE POSITION:
The Director, Global Regulatory Affairs 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. As a Director, Global Regulatory Affairs, you are also responsible for implementing the strategy, which often entails engaging regulatory authorities, authoring submissions, and interacting with the authorities throughout the regulatory review. This is a highly collaborative role, one in which you will often become an embedded member of the client’s organization where you will proactively be influencing and shaping the regulatory environment for business goals and strategies.
This remote role prefers candidates based in the Eastern or Central Time Zones.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:
- 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.
- Establish and maintain healthy, long-term relationships with clients to generate repeat business and referrals.
- Support business development efforts as a Sales SME, applying expertise and performing presentations that demonstrate the benefits of our services to potential clients, and support proposal development for new opportunities.
- Remain current on global regulatory requirements and approval processes.
- Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.
- All other duties as assigned
Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by an employee with a disability, unless such accommodation would cause an undue hardship for EVERSANA. If reasonable accommodation is needed to perform the essential functions of your job position, please contact Human Resources.
EXPECTATIONS OF THE JOB:
- Partner with clients to achieve business objectives.
- Understand the client’s needs and recommend regulatory strategies and tactics.
- Cross functional collaboration to ensure objectives and milestones are met.
- Consultative services and selling to clients, ensuring positive front-line contact.
- Mentoring and knowledge sharing with other regulatory associates.
- Travel -Up to 10% required (may occasionally exceed 10%)
- Hours - 40+ hours/week
The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.
An individual in this position must be able to successfully perform the expectations listed above.