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Director, Global Medical and Promotional Regulatory Affairs

Jazz Pharmaceuticals

California, CA
12 days ago
$188,800.00 - $283,200.00

This Job Position Has Expired

This job listing is no longer available for applications. The position may have been filled or the posting period has ended.

Job Description

Join Jazz Pharmaceuticals as the Director of Global Medical and Promotional Regulatory Affairs, where you'll lead the review of promotional materials and ensure compliance with FDA regulations. Your expertise will play a crucial role in supporting product launches and collaborating with various departments to deliver life-changing medicines.

Key Responsibilities

  • Lead the promotional material review committee for assigned products
  • Provide input on promotional materials to satisfy FDA regulations
  • Present risk analysis to leaders in various departments
  • Serve as the Promotional Regulatory Affairs lead for new product launches
  • Manage regulatory aspects of promotional material reviews
  • Collaborate with multiple departments for efficient material review
  • Lead interactions with FDA/OPDP for assigned products
  • Stay current on evolving FDA regulations

Required Qualifications

  • B.S or B.A. degree in a scientific discipline or equivalent
  • Substantial pharmaceutical industry experience
  • Proven experience in regulatory affairs advertising and promotion
  • Strong understanding of FDA regulations and guidelines
  • Strong judgment and decision-making skills
  • Excellent collaboration, verbal and written communication skills

Preferred Qualifications

  • Advanced degree in a scientific discipline (e.g. PharmD)
  • Experience with Oncology and new product launch support

Benefits & Perks

Medical, dental and vision insurance401k retirement savings planFlexible paid vacationDiscretionary annual cash bonus or incentive compensationDiscretionary equity grants