Director, Global Regulatory Consulting

Company Description

At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us!

Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs.  We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.  

Job Description

THE POSITION:

The Director, Global Regulatory Consulting 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 Consulting, 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams.  These results are achieved by partnering with clients to ensure their products or services meet governing regulations. Our work varies from client to client, but consistently draws upon regulatory expertise, research and organization skills, effective communication to a variety of roles and decision makers, and technical writing skills that transform complex products into simple descriptions. As the primary contact with each client, we also serve as the project manager, breaking complex deliverables into trackable tasks and then ensuring all project goals and timelines are achieved.

• 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.

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

EXPECTIONS 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.
• Consu