Eisai US · 3 days ago
Director, Global Regulatory Affairs, Growth Markets
Nutley, NJ
Full-time
Hybrid
Director/Executive
$201K/yr - $264K/yr
10+ years expEisai US is a growing pharmaceutical company focused on neurology and oncology, dedicated to satisfying unmet medical needs. The Director, Global Regulatory Affairs, Growth Markets will provide regulatory leadership and strategic direction for products in growth markets, ensuring compliance and alignment with global strategies.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
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
Preferred
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
Benefits
Eisai Inc. Annual Incentive Plan
Eisai Inc. Long Term Incentive Plan
Company employee benefit programs
Company
Eisai US
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. It is a sub-organization of Eisai.
1001-5000 employees
H1B Sponsorship
Eisai US has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (21)
2023 (12)
2022 (41)
2021 (14)
2020 (22)
Funding
Current Stage
Late StageLeadership Team
Tricia Brooks
VP and Head of Office, Government Affairs & Policy
Recent News
2026-01-06
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