CMC experience is important, but strong, proven leadership skills are imperative...... This is an unbelievable opportunity to make a big and immediate impact in this organization!! MUST HAVE PRIOR REGULATORY AFFAIRS CMC EXPERIENCE WORKING WITH BIOLOGIC PRODUCTS. A strong Director, Regulatory Affairs, CMC is needed by a rapidly growing biologics company to help them upgrade the processes and procedures in their key, global vaccine manufacturing plant. Picture this.....as you look back one year from now you will have:
quality and manufacturing 2. Significantly improved relationships with the FDA and other global regulatory authorities 3. Helped with the transition of the manufacturing facility from one product to multi product production 4. Developed and mentored existing regulatory affairs staff and additional staff as hired 5. Provided solid regulatory guidance to the project teams 6. Led the global expansion; prepared dossiers, shared knowledge about and implemented the requirements in different global countries 7. Improved the quality of the US submissions to the highest standards 8. Gained the respect of the senior management team and built credibility through your knowledge and outstanding communication skills send resumes to: sue.komers@eliteresourcesolutions.com |
Director, CMC - Licensed Products #9144
Elite Resource Solutions, LLC
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