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Associate Director Regulatory NY Open (J#39014)

Associate Director Regulatory Affairs - Latin America

My client is a worldwide leader in the manufacturing, research and development and marketing of innovative products. Their success is based on a commitment to creating and maintaining long-term customer relationships, strong leadership and consistent innovation around new products. As one of the top consumer health companies worldwide, my client is looking to add this key member to their OTC team. If you are an ambitious professional and meet the criteria below, this may be the position to further enhance your career.

Job Responsibilities:
- Support Latin America and Consumer Health Business initiatives - Develop, Implement and Maintain Regulatory Affairs strategies for new/existing products in 25 countries. - Compile Regulatory submissions - Liaise with Latin American Affiliates, manufacturing operations and project teams. - Ensure GMP-related documentation is in conformance - Liaise between plants and regulatory groups

Job Requirements:
- B.S. Degree: Master s or PhD degree preferred - Minimum 7 years experience in Regulatory Affairs OTC environment - Minimum 3 years people and international management experience - Minimum 3 years hands-on CMC and international submission experience - Strong knowledge of pharmaceutical development process - In-depth understanding of cGMP s, Latin America Regulatory requirements - Fluent in English and Spanish or Portuguese - 25% travel required
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