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Regulatory Affairs Lead

Oak Ridge National Laboratory
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Regulatory Affairs Manager

Eckert & Ziegler Isotope Products, Inc.
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Regulatory Affairs Manager

Logistics Management Institute
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AVP Regulatory Affairs & Product Filings

Hartford Steam Boiler Inspection and Insurance Company
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Senior Manager, Regulatory Affairs, Advertising and Promotion

s policies and supports management decisions and goals. **Skills and Experience:** + Minimum of two years of experience in a Regulatory ad/promo directly reviewing promotional materials. Product launch experience preferred. + Experience with Veeva PromoMats preferred. + General knowledge of advertising/promotional regulations, guidelines and best practices + Prior experience with new product launches and Subpart H/E products highly desired. + Strong business acumen and ability to make sound decisions that contribute positively to the business. + Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism. + Excellent oral and written communication skills are a must, as are superior planning skills. + The candidate should be detailed-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment. **Supervisory Responsibilities:** + None, initially. May hire and manage direct reports in the future. **Computer Skills:** Proficiency in MS Office Suite applications. Adobe Acrobat and Veeva Vault systems experience preferred. **Education/Experience Required:** Bachelor’s degree (BS/BSc or BA), preferably in a scientific or health-related discipline, 5 years of experience in the biotechnical or pharmaceutical industry, and a minimum of 2 years’ experience in a Regulatory capacity with a relevant background. Prior experience reviewing promotional materials
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Senior Regulatory Affairs Specialist

Orange County Regulatory Affairs Discussion Group (OCRA)
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