Regulatory Affairs Specialist

Detalles de la oferta

.About Phibro Animal Health CorporationPhibro Animal Health Corporation is a publicly traded organization with a rich history spanning nearly 100 years of service. The Company is a global manufacturer of medicated feed additives, feed ingredients, advanced nutrition solutions, vaccines, and specialty chemicals for various industrial markets. Phibro's revenues are in excess of $820 million and are supported by over 1500 employees worldwide.The Regulatory Affairs Specialist is an integral part of our Regulatory Affairs team based out of our Mexico - Guadalajara site.Position DetailsThe Regulatory Affairs Specialist plays a key role in ensuring the maintenance of the product portfolio including Medicated Feed Additives, Nutritional Specialties, and Biologicals, managing new registrations and maintenance of the existing ones working with local and international teams, as well as with the regulatory supplier applicable in Mexico and Central America. This position is at office full-time for the right candidate and may include some travel.Responsibilities of the role include, but are not limited to the following:Oversee, plan, prepare and submit new applications and support the existing registrations, ensuring accuracy, completeness, and compliance with regulations and guidelines.Label approval and coordination: Review, approve labeling and coordinate with multi-disciplinary teams their implementation.Utilize databases to maintain current and complete documentation for animal health products.Ensure regulatory compliance by preparing and directing audits for commercial and contract manufacturers operation in Mexico.Monitor regulatory requirements and stay abreast of industry best practices in the animal health industry and assess their impact on the registrations and provide strategic guidance to ensure ongoing compliance with regulatory requirements.Develop and implement regulatory strategies for assigned projects.Key CompetenciesInterpersonal Skills / CommunicationPrioritizing and Organizing WorkManaging TimeDemonstrating InitiativeSkillsInterpersonal skills sufficient to communicate verbally and in writing with others in an objective and cooperative manner.Advanced organizational skills.High degree of time management skills and ability to handle multiple priorities and projects at once.Extremely high level of attention to detail and high standard of quality.Must be accurate, detail-oriented, and thorough.Ability to work independently.Demonstrated resourcefulness and initiative.A motivated self-starter, work well in groups and demonstrate excellent customer service.Must be proficient using Email, phones, cell phones, and office equipment.Proficiency in Microsoft Office Products.Education & ExperienceBachelor's degree, preferably in a scientific field or animal health with 2 years of work experience in regulatory affairs for animal health


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Requisitos

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