* INTERNATIONAL Regulatory Affairs Expert* Pharma/OTC/Devices * Spanish Fluency Required

PLEASE NOTE: Your resume will not be properly formatted if you respond to this posting via monster board or another job board.  To properly respond, you should format your resume in MS Word or Corel WordPerfect and send it to Christie@jobquestsite.com as an attachment.  Please visit our website at http://www.jobquestsite.com to view other career opportunities. PLEASE DO NOT RESPOND TO THIS POSTING IF YOUR BACKGROUND DOES NOT MATCH THE REQUIREMENTS DETAILED BELOW.   OVERVIEWEmphasis will be on the direct maintenance and growth of  Latin American business, while providing support for the maintenance and growth of current other international business. KEYWORDS:  OTC, Personal Care, Consumer Health, Scientist, Chemist, Pharmaceutical, Pharmaceutics, PhD, PharmD, Engineer, Healthcare, Medical, Product Development, Hair, Skin, Oral, Cream, Lotion, Gel, Solid, Liquid, Tablet, Capsule, Regulatory, Affairs, Dialects, Linguist, FDA, ICH, Canada, European Union, Latin America DUTIES/RESPONSIBILITIES Coordinates with respective employees and consultants and/or agents to establish timelines, requirements, roles, and responsibilities for registering Latin America and/or other company brands in international markets as needed Provides and updates the necessary documentation for registering Latin America products and/or other company products in international markets as needed Provides responses to technical questions raised by the regulatory authorities Provides regulatory recommendations to management regarding international sales and marketing of Latin America products and/or other company international products Oversees maintenance and archiving of records for all registrations and correspondence with international authorities in an electronic tracking database and/or a core dossier Is fluent in country-specific requirements for manufacturing, sales, and marketing of international products, particularly those in Latin America (all dialects) Willingness to work across time zones to coordinate support for international markets QUALIFACTIONS/SKILLSAdvanced degree (Ph.D., Pharm.D., MS) in pharmaceutical sciences, life sciences or chemistry required, with related International business education a plus.  EXPERIENCE: Five to ten years of international regulatory affairs experience in pharmaceutical, OTC drug and cosmetic products, and medical devices; Advanced knowledge of ICH regulations, and regulations, policies, procedures, drug development guidelines and compliance of Latin American ministries of health, Health Canada, EU, and like agencies; Strong scientific and/or clinical background;  Experience assembling formal regulatory documents and submissions; Demonstrated ability to communicate effectively, both orally and in written form, and to convert scientific and regulatory information into terms understood by a lay person; Demonstrated ability to manage multiple projects and stay on timelines; Demonstrated ability to formulate global regulatory strategies based on thorough understanding of the products and hands-on experience in regulatory procedures to affect competitive and speedy product approvals; Demonstrated ability to successfully resolve regulatory milestones, coordinate labeling negotiations; Experience with M/S Word, Excel, Access, Outlook, and PowerPoint; Demonstrated ability to work in a team; Experience in Latin America markets Bilingual – Fluent Spanish skills, verbal and written, including broad understanding of variances between dialects. COMPENSATION/BENEFITSExcellent Relocation PackageFull Benefits$110K base, negotiable DOEBonus/Stock option potential    MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: Cleveland, TN JOB CATEGORY: Legal TYPE: Full Time, Employee JOB REFCODE: CCW4003 COMPANY: Management Recruiters of Myrtle Beach, Inc. CONTACT NAME: Christie Whisnant, Account Executive EMAIL: Apply by Email