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About AbbVie

AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.  For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.​

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Director, Regulatory Affairs, Oncology Early Development

Regulatory Affairs
1901730 Requisition #
Thanks for your interest in the Director, Regulatory Affairs, Oncology Early Development position. Unfortunately this position has been closed but you can search our 701 open jobs by clicking here.
  • Bachelor degree in a life sciences, chemistry, or related discipline. Advanced degree preferred
  • 8 to 12 years of experience in Regulatory Affairs (minimum 4 years within oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment. International regulatory experience required
  • Knowledge of current US and EU regulations for oncology drugs, including experience preparing, filing, and performing life-cycle management of applications and all supportive amendments, supplements, and annual reports to the United States Food and Drug Administration (US-FDA) in eCTD format
  • Knowledge of oncology global clinical trial regulations, including experience with submission of Clinical Trial Applications (CTAs) to global regulatory agencies and management of regulatory aspects of clinical trials in accordance with Good Clinical Practices (GCP) requirements
  • Experience in submissions of Proposed Pediatric Study Request (PPSR), deferral requests, study protocols and clinical study reports (CSRs)
  • Experience with health authority meeting preparation
  • Proven ability to independently manage critical projects as part of an interdisciplinary team. In addition, the candidate should have experience preparing, managing and submitting major regulatory submissions.
  • Ability to successfully manage multiple projects to deadlines
  • Experience with regulatory intelligence activities and pharmaceutical registration databases to support product approval strategies

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients.  As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.







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