Director, Global Regulatory Affairs, Growth Markets

Eisai • Nutley, NJ

51d • Hybrid

About The Position

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) 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.

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.
• 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.
• Ability to assume accountability for a project goal/objective
• Excellent written and oral communication skills

Nice To Haves

• Advanced degree (Master's or PhD) is a plus.
• Desirable to have previous experience in therapeutic area
• Prior experience leading regulatory strategy teams directly in a supervisory/leadership capacity preferred.

Responsibilities

• 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.

Benefits

• Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits.
• Certain other benefits may be available for this position, please discuss any questions with your recruiter.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees