Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since then we have rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs.
Eisai recognizes that we are the Company’s greatest asset. To this, Eisai is committed to providing us an enabling and empowering work environment that allows us to grow and thrive. In our diverse organization, we adhere to a strict commitment to our values of Integrity, Respect, Professionalism, Quality and Teamwork. We therefore invite you to explore this job opportunity or any others that may match your qualifications and interests.
The Senior Manager, Regulatory Affairs Growth Markets, 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.
Responsibilities include but are not limited to:
1. Contributing to the development and implementation of regulatory strategies for the assigned projects. Leading issue resolution of regulatory risks by identifying, escalating and monitoring issues.
2. Organizing 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.
3. Contributing to the planning, execution, and assessment of product life cycle management activities and strategies.
4. Assisting, 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.
5. Contributing to the department-wide work-stream/initiatives, as assigned.
JOB REQUIREMENTS: 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 Here at Eisai, we are rewarded with highly competitive salaries, incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, and other great programs.
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, including, but not limited to, race, color, national origin, religion, sex, age, disability, pregnancy, ancestry, creed, alienage or citizenship status, sexual orientation, gender identity and expression, marital status, military/veteran status, genetic information, or any other protected characteristic as established by law.
Eisai is an Equal Opportunity Employer – Minority / Female / Disability / Vet from tblHiringOrgDefaultshttps://eisai.contacthr.com/71970023.jpg />