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Associate Director, Regulatory Affairs

Req #: 17001062
Location: Summit, NJ US
Job Category: Regulatory Affairs
Work Location: 86 Morris Avenue CELSUM 07901
Organization: Celgene Corporation
Schedule: 40
Shift: Day Job
Employee Status: Full time
Job Type: Regular
Job Level: Director
Travel: Yes, 10 % of the Time
Other Locations:US- NJ- Summit East

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

Develop and implement global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC. Lead global and/or regional regulatory team on assigned projects. Develop and execute US regulatory strategy and contingencies for assigned projects. Serve as the primary interface for FDA on assigned projects. Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc.  Work with cross-functional teams to define contributions to submissions.  Lead regulatory submission teams for projects assigned.  Prepare project/study team for FDA and other regulatory health agency meetings, as required. Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Development Teams and Study Teams, etc. Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances. Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.

Skills/Knowledge Required:

  • Bachelor’s degree in scientific discipline; advanced scientific degree preferred.
  • Experience in multiple phases of development in various therapeutic areas. Experience in inflammatory and immune-mediated diseases a plus.
  • A minimum of 7 years pharmaceutical industry with a minimum of 5 years in regulatory affairs.  Global experience desirable.
  • Thorough knowledge of the drug development process, with a focus on IND and NDA processes.
  • Demonstrated experience in preparing new IND and/or NDA submissions.
  • Knowledge of global regulatory guidances as they relate to the overall global regulatory strategy.
  • Results driven and team-orientated with the ability to influence outcomes as necessary skills in the environment.
  • Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
  • Must be able to innovate, analyze and solve problems with minimal supervision and exceptionally keen skills for  attention to detail.

Domestic and occasional International travel may be necessary.

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