Senior Manager, Regulatory Affairs, 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 (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.

Summary

The GRA-GM Senior Manager, will work closely with regulatory colleagues at affiliates/business partners to support the development and implementation of regulatory strategies to allow timely submissions, approvals, and optimal labels, by working closely with all relevant stakeholders within Eisai. This position contributes to the planning, execution and assessment of product life cycle management activities and strategies. In addition, this person will also be encouraged to continuously expanding his/her knowledge in Growth Markets regulatory environment and local requirements, acting as a point of contact between the affiliate/partner and the global functions within Eisai to create high-quality dossiers to enable an efficient and effective registration process aligned with the commercial objectives of the company.

Job Description

Essential Functions

* Contributes to the development and implementation of regulatory strategies for the assigned projects. Lead issue resolution of regulatory risks by identifying, escalating and monitoring issues.

* Organize resources and processes across multiple teams / functions to develop and deliver complete regulatory submissions within agreed timeframes. Providing regulatory support to project teams for assigned projects.

* Contribute to the planning, execution, and assessment of product life cycle management activities and strategies.

* 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.

Requirements

* BS/BA in Life Sciences in a relevant field with minimum 5 years of broad pharmaceutical industry experience, including 3 years of experience with new/innovative drug registration strategy/submissions, or

* MS with 4 years of broad pharmaceutical experience including 2+ years of experience with new/innovative drug registration strategy/submissions.

* An advanced degree (PharmD or PhD) preferred

* Previous regulatory experience in Emerging/Growth Markets (international) region, preferred

* Experience of the Drug Development process and working with international/global project teams

* Working knowledge of relevant drug laws, regulations and guidance's/guidelines

* Desirable to have previous experience in therapeutic area

* Ability to assume accountability for a project goal/objective

* Experience in leading team discussion to resolve and reach agreement on project issues.

* Excellent written and oral communication skills

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.

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