Senior Manager, Global Regulatory Affairs - Oncology

Woodcliff Lake, New Jersey
Cometitive salary and comprehensive benefits package
May 07, 2018
Jul 07, 2018
Full Time

Senior Manager, Global Regulatory Affairs - Oncology

The Senior Manager, Global Regulatory Affairs will develop and implement 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. In addition, this person contributes to the clinical development plans, global regulatory strategic plans, and provides advice on US regulatory clinical trial and marketing authorization requirements to the International Project Teams (IPTs) or Regulatory Sub-team.

Responsibilities include but are not limited to:

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

- 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

- 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 Sciences in a relevant field with 8+ years of broad pharmaceutical experience, including 6+ years of new drug regulated product strategy/submissions; a Master's Degree with 6+ years of related Regulatory experience, including fellowship experience; or a PharmD or PhD with 3+ years of related Regulatory experience, including fellowship experience.
• Experience of the Drug Development process and working with international project teams
• Working knowledge of relevant drug laws, regulations and guidance's/guidelines
• Desirable to have previous experience in Oncology 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

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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