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Executive Director, Regulatory Affairs

Req #: 1800461
Location: Summit, NJ US
Job Category: Regulatory Affairs
Work Location: 86 Morris Avenue CELSUM 07901
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- NJ- Summit East

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

PREREQUISITES

Advanced scientific discipline degree: 12-15 years pharmaceutical industry experience, with 8-10 years in regulatory area. MD, PhD or PharmD preferred.

Responsibilities will include, but are not limited to the following:

Develop global therapeutic regulatory strategies and operational plans for identified investigational and marketed products. Review/provide counsel on product development plans. Working with regional staff, assemble the global regulatory plans for identified projects/products. Influences and imparts broad expertise regarding US and international regulatory environment. Provides strategic and operational advice to the development and commercialization teams, serving as the primary global point person for assigned projects. Evaluates emerging regulations and changing regulatory landscape for impact and provides strategic advice for assigned projects. Provides leadership to the larger regulatory team that supports assigned projects and manages assigned regulatory staff. Acts as lead Regulatory person; providing primary interface for FDA on assigned projects. Works with the regulatory product managers (submissions) and regulatory operations group, for preparation, production and submission of health authority documents using internal & external resources. Works with regional international staff for diverse health authority submissions. Identifies issues or is assigned projects that will impact Celgene, regulatory affairs or projects and provides strategies for dealing with them. Acts as key regulatory representative on various cross-functional teams as assigned, which may include key business development assessments.

Skills/Knowledge Required:

  • Advanced degree in scientific discipline; MD, PhD or PharmD preferred, experience in oncology or inflammatory disease drug development preferred.
  • 12-15 years pharmaceutical industry experience, including 8-10 years in regulatory affairs. Global experience strongly preferred with command of US experience and EU background desired.
  • Thorough knowledge of the drug research, development, and commercialization process.
  • Demonstrated specific expert in one or more key areas – Drug Development/CMC/Pharmtox/ Biopharmaceutics/Clinical/Promotional.
  • Inter-dependent partnering skills, team-oriented and ability to influence outcomes necessary. Sensitivity and experience with non-domestic organizations/cross-cultural environments.
  • Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
  • Must be able to innovate, analyze and solve critical/complex business problems.

#LI-POST

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.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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