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Senior Director Regulatory Affairs

  • Job type: Permanent
  • Location: Bridgewater
  • Salary: $250000 - $280000 per annum
  • Job reference: MLSN11018
  • Sector: EPM Scientific, Regulatory
  • Date posted: 10/01/2018

Job Description

Job Summary
Our client, a global multi-billion dollar pharmaceutical company is looking for a Senior Director Regulatory Affairs, in a brand new growing position!

The candidate will be Responsible for the Following Duties:
  • Responsible for Global Regulatory leadership and oversight, including development and successful execution of regulatory strategies
  • Assures regulatory strategies reflect best in class application of scientific, therapeutic and regulatory expertise and knowledge and ensures programs meet all applicable regulatory and business requirements.
  • Accountable for ensuring or contributing to Global Regulatory Strategies and implementation plans developed for assigned projects
  • Regulatory knowledge of the regulatory environment and how this impacts regulatory strategy and implementation. Understanding of regulatory agency philosophy and guidelines.
  • Bachelor of Science degree; advanced scientific-related degree desired
  • 15+ years pharmaceutical drug development (pharmaceutical industry or institutions) with minimum of 10 years in regulatory affairs
  • Strong scientific knowledge and regulatory experience in the assigned TA(s).
  • Proven track record of leadership in the pharmaceutical industry.
  • Strong global regulatory knowledge and proven track record in leading successful submissions, interactions with regulatory authorities, approvals and complex developmental programs in the US
  • Excellent interpersonal, verbal and written communication skills with a demonstrated ability to resolve conflict situations and influence regulatory authorities, as well as internal and external stakeholders
  • Strong analytical and problem-solving skills
Please apply below, if you are interested!
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