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. If this is your profile, we want to hear from you.

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

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

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 is committed to a policy of equal employment opportunity for all employees and applicants. The Company also strives for a work environment free from discrimination and harassment. It is Eisai's policy to comply with all applicable federal, state and local laws and regulations regarding nondiscrimination in employment and not to discriminate against any employee or applicant for employment on the basis of any protected status.