Director, Global Regulatory Affairs, Growth Markets

Director, Global Regulatory, Growth Markets

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.

The Director, Global Regulatory, Growth Markets will be responsible for providing regulatory leadership and strategic direction for Eisai's products in growth markets. This role will focus on the development and execution of regulatory strategies for products under development, post-approval activities, and life-cycle management, with a particular emphasis on the regulatory landscape in growth markets such as Latin America, the Middle East, and Africa.

The Director will manage regulatory submissions, registrations, and lifecycle management activities for new and existing products in these regions, ensuring alignment with global strategies and local regulatory requirements. This role requires a strong understanding of the regulatory approval processes in key growth markets, along with the ability to effectively collaborate with cross-functional teams to expedite product approvals. This role requires experience with MAA and post-approval applications.

Essential Functions

• Provide strategic leadership in the development, registration, and life-cycle management of products in growth markets.
• Ensure that regulatory strategies align with business objectives and comply with local regulations.
• Develop and implement regulatory strategies for market entry, product registrations, and lifecycle management for new and existing products across growth markets, including Latin America, the Middle East, and Africa.
• May serve as the growth markets regulatory representative on the project team throughout the product lifecycle.
• Assists, as needed, interactions and negotiations with health authorities. May autonomously handle routine communications with regulatory authorities and may participate in phone or in-person meetings.
• Contribute to the department-wide work-stream / initiatives, as assigned.
• Ensure continued engagement, development and performance management of staff.
• Determining timelines and budgets for program activities and report accordingly.
• Lead and participate in global regulatory initiatives and committees.

Requirements

Bachelor's degree in Life Sciences in a relevant field with minimum 10 years of broad pharmaceutical industry experience, including 8 years of direct Regulatory Affairs experience with new / innovative drug registration strategy / submissions. Advanced degree (Master's or PhD) is a plus. Any regulatory experience in Emerging / Growth Markets (Latin America, Middle East and / or African markets) region is required. Experience in managing the preparation of a marketing application (MAA) and lifecycle management in both CTD format and non-CTD format. Experience of the Drug Development process and working with cross functional international / global project teams. Position has both direct and indirect reports in US and UK. Demonstrated success in leading and managing teams is required. Has cultural awareness and experience of working with people from different cultural backgrounds. Working knowledge of relevant drug laws, regulations and guidance's / guidelines. Excellent operational skills including planning, organizing and ability to motivate and lead others. Desirable to have previous experience in therapeutic area. Ability to assume accountability for a project goal / objective. Prior experience leading regulatory strategy teams directly in a supervisory / leadership capacity preferred. Excellent written and oral communication skills.

Our preference is for hybrid in our Nutley, NJ office (in-office Tuesday, Wednesday, Thursday every week); we will also consider remote based.

Eisai Salary Transparency Language : The annual base salary range for the Director, Global Regulatory Affairs, Growth Markets is from : $200,800-$263,600. Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, please discuss any questions with your recruiter.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information : Right To Work E-Verify .