Associate Director, Global Regulatory Affairs - Oncology

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

Associate Director, Global Regulatory Affairs - Oncology

The Associate Director, Regulatory Affairs will be responsible for providing all aspects of regulatory support for supplemental indications associated with an approved Oncology agent. In addition, this position will serve as the lead support for early phase Oncology compounds. This person may participate in departmental work streams designed to improve development cycle timelines or to improve regulatory processes.

Responsibilities include but are not limited to:

1. Regulatory Submissions (IND/NDA): Monitoring regulatory submission activities and reviewing regulatory documents prior to submission to ensure overall quality, compliance and timeliness. Partnering with project teams to assess regulatory support needs and align resources (i.e., sub teams) to provide regulatory support

2. Interfacing with Authorities: Acting as the point of contact with regulatory authorities for assigned product(s). Leading calls or meetings with regulatory authorities.

3. Regulatory Strategy Development: Contributing to the development of global regulatory strategies across programs for own functional area and region. Identifying, monitoring and resolving regulatory issues and reporting progress to management

4.Compliance: Ensuring compliance with all applicable laws / regulations of each country in which we do business. Demonstrating high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians. Reporting legal, compliance and ethical violations in a timely manner

5. Life Cycle Management: Leading the planning, execution and assessment of product life cycle management activities and strategies

Job Qualifications:

• BS/BA in Life Sciences in a relevant field with 10+ years of broad pharmaceutical experience, including 6+ years of new drug regulated product strategy/submissions; a Master's Degree with 8+ years of related Regulatory experience, including fellowship experience; or a PharmD or PhD with 5+ years of related Regulatory experience, including fellowship experience.

• Experience interacting with the FDA and ex-US health authorities

• Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document

• Experience developing global regulatory strategies in coordination with clinical plans and marketing objectives

• Experience in successfully leading teams and the ability to broadly represent GRA functions on project teams

• Demonstrated matrix leadership skills and the ability to work effectively in a matrix team across multiple disciplines

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

Interested candidate 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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