MUST HAVE PRIOR EXPERIENCE WORKING IN A REGULATORY AFFAIRS DEPARTMENT TO BE CONSIDERED FOR THIS POSITION. This is a very exciting new CMC Regulatory Affairs management role that is located in an area that offers mountains, beaches, cities, wilderness and lots of opportunities for outdoor adventures. This is a great opportunity to improve both your career and your quality of life! Our client (a very stable, global pharmaceutical company) is looking for a Regulatory Affairs leader for their manufacturing plant in North Carolina. This will be a highly visible and autonomous role with the ability to be an influential decision maker. We need a real "go-getter" because there is a lot to be accomplished this year. They offer a very good compensation package that includes a bonus and great benefits. Requirements: • Minimum of six years of Regulatory Affairs CMC experience (generic experience is a plus) • Solid dosage experience preferred • Must have supervisory experience and a love of mentoring (there will be four direct reports) • Must have experience writing and filing CMC sections of ANDAs and/or NDAs • Must have experience interacting with the FDA • Must have experience with manufacturing changes and change control • Electronic documentation experience a big plus send resumes to: sue.komers@eliteresourcesolutions.com |
Regulatory Affairs CMC Management Position Job # 9173
Elite Resource Solutions, LLC
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