Associate Director/Director, Regulatory Affairs

Associate Director/Director, Regulatory Affairs
MON-03804

Amylin Pharmaceuticals, founded in 1987, is a growing biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Our Research and Development team has significant experience in metabolic diseases and is focused on investigating the biological actions and utilities of bioactive peptides and other compounds as potential drug candidates. Amylin has amassed significant research and clinical expertise in metabolic medicine, including the areas of diabetes and obesity, and we’re always looking for more talented and energetic professionals with not only the requisite knowledge & experience, but also the desire and passion to help us sustain our momentum and competitive edge.

Currently, we have a great opportunity for a highly motivated, hands-on professional to identify and describe CMC-related program issues that impact regulatory strategy.

Specifically, you will:

• Provide appropriate framework to lead productive and efficient group discussion of regulatory impact of CMC issues, resulting in effective decision-making
• Develop and present risk assessments of various decision options for addressing CMC issues, and the impact of such options on regulatory strategy
• Capture key messages impacting Project Team in written communications, e.g. RegCMC strategic position statements
• Write, review, and edit CMC-related submissions to FDA, e.g. INDs, NDAs (CTD Module 3), and FDA meeting briefing documents
• Present and negotiate regulatory strategy at meetings with FDA
• Prepare written responses to FDA during NDA review process
• Manage IND amendment strategy and strategic elements for post-approval supplements to NDA/product lifecycle enhancement
• Contribute to overall Regulatory Affairs line function business strategy and operations through member

This position requires:

• A BA/BS with 5-7 years of direct pharmaceutical industry experience and at least 3 years experience in Regulatory Affairs
• Knowledge of FDA regulations and guidance for CMC and biotechnology products
• Experience with NDA submissions, FDA meetings and negotiations
• A solid understanding of CMC elements of drug development, GMP requirements, CTD submission content and format requirements, and technical aspects related to CMC development of dispersed systems and aseptic products
• Excellent management, leadership, organizational, and written/verbal communication skills.

By “Challenging Science,� Amylin challenges conventional thinking to create innovative approaches to the discovery, development and commercialization of novel therapies for metabolic diseases. Amylin’s approach and dedication are rooted in the belief that we will be “Changing Lives� for millions of people. At Amylin, you’ll have the chance to truly make a difference in people’s lives. We also recognize top talent when we see it, and we reward it, generously, through our competitive compensation & benefits program. Amylin is proud to be an equal opportunity employer.



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AMYLIN

Challenging Science. Changing Lives.