Manager, Global Regulatory Strategy - Oncology

Woodcliff Lake, New Jersey
Competitive salary and Comprehensive benefit package
May 07, 2018
Jun 02, 2018
Full Time

Manager, Global Regulatory Strategy - Oncology

The Manager, Global Regulatory Strategy will research and assist in the development and implementation of regulatory strategies to facilitate optimum global approval of new medicinal products. This position contributes to the planning, execution and assessment of product life cycle management activities and strategies that are summarized in both clinical development and global regulatory strategic plans.

The Manager, Global Regulatory Strategy will provide advice on US regulatory clinical trial and marketing authorization requirements to the Regulatory Sub-team and the International Project Team (IPT). In addition, this role will have ownership of the preparation and submission of documents to Regulatory Authorities (Annual Reports, Protocol Amendments etc.).

Responsibilities include but are not limited to:

• 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

• Developing and implementing regulatory strategy for the assigned projects. Leading issue resolution of regulatory risks by identifying, escalating and monitoring issues

• Contributing to the planning, execution, and assessment of product life cycle management activities and strategies

• Contributing to, and implementing strategy for interactions and negotiations with health authorities. May autonomously handle routine communications with regulatory authorities

• Contributing to the department-wide work-stream/initiatives, as assigned

Job Qualifications:

• BS/BA in Life Science or relevant field, PharmD or PhD preferred

• Excellent written and oral communication skills

• Familiarity with the drug development process (2 years of broad pharmaceutical industry experience in a related regulatory role)
• Working knowledge of relevant drug laws, regulations and guidance’s/guidelines
• Ability to assume accountability for a project goal/objective
• Participate in team discussion to resolve and reach agreement on project issues

Interested candidates should apply for consideration at:

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

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