Director, Regulatory Affairs Job
Celgene - Berkeley Heights, NJ

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Job Title:
Job ID: 12867
Location: Berkeley Heights, NJ - 400

Offsite Territory:
Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Regulatory
Department: Regulatory Affairs - 3691

About Celgene

Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Prerequisites

  • Completed Bachelor’s degree in a scientific discipline required (advanced degree preferred).
  • Oncology experience highly preferred.
  • Must have at least 10 years pharmaceutical industry experience in clinical regulatory affairs, inclusive of at least 7 years experience in a senior regulatory leadership role formulating strategy and driving decision-making.
  • Must be able to travel overnight for business 15% or more, depending on project needs.
  • Prior direct or matrixed employee management experience preferred.
  • Established regulatory accomplishments in a different therapeutic area also desired.
Responsibilities will include, but are not limited to, the following:

1. Serve as Global Regulatory Strategy Leader for late stage marketed product with multiple indications. For each indication, will:
2. Develop and create strategy for long-term planning at a cross functional level for product, consistent with the corporate and project objectives.
3. Represent regulatory in senior management discussions and present issues accordingly.
4. Interface with international affiliates on regional regulatory strategy and implementation plans.
5. Provides strategic direction to Regional Regulatory Strategy Lead in preparing teams for project related interactions with Regulatory Agency(ies).
6. May engage with Regulatory Agency(ies) on project related interactions.
7. Provide innovative solutions to challenging opportunities.
8. Responsible for the development of global regulatory strategies, in collaboration with the Global Regulatory Team and Strategic Regulatory Intelligence and Policy, which are consistent with the global Project Team goals and objectives.
9. Accountable for ensuring the appropriate implementation of the global regulatory strategy.
10. Identify issues proactively (i.e. regulatory or competitive) that will impact programs and provide strategies to address them. Communicate these issues to the Global regulatory strategy leader, global regulatory sub-team and to functional management.
11. Provides insight and recommendations on health authority guidance in collaboration with the strategic liaison, policy, and regulatory intelligence group.
12. Conduct Business Development diligence efforts, if assigned.
13. Be a strategic partner and team player in the various decision-making committees within the company.
14. Manage up to at least 2 direct reports.
15. Engage with patient support services at Celgene to maximize regulatory and development strategies.

Minimum

Skills/Knowledge Required:
  • Completed Bachelor’s degree in a scientific discipline required.
  • Must have at least 10 years pharmaceutical industry experience in clinical regulatory affairs, inclusive of at least 7 years experience in a senior regulatory leadership role formulating strategy and driving decision-making.
Preferred Skills/Knowledge:
  • Completed Master’s (or higher-level degree) in a biological sciences concentration is preferred.
  • Oncology experience highly preferred.
  • Prior direct or matrixed employee management experience preferred.
  • Established regulatory accomplishments in a different therapeutic area also desired.
Equal Employment Opportunity

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

About this company
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Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.