Director, Global Medical and Promotional Regulatory Affairs
Jazz Pharmaceuticals
California, CA
12 days ago
$188,800.00 - $283,200.00
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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