Regulatory Affairs Associate Omaha United States,
Perrigo Company plc, a leading global healthcare company, delivers value to its customers and consumers by providing Quality Affordable Healthcare Products®. Founded in 1887 as a packager of home remedies, Perrigo has built a unique business model that is best described as the convergence of a fast-moving consumer goods company, a high-quality pharmaceutical manufacturing organization and a world-class supply chain network. Perrigo is the world's largest manufacturer of over-the-counter ("OTC") healthcare products and supplier of infant formulas for the store brand market. The Company also is a leading provider of branded OTC products throughout Europe and the U.S., as well as a leading producer of "extended topical" prescription drugs. Perrigo, headquartered in Ireland, sells its products primarily in North America and Europe, as well as in other markets, including Australia, Israel and China.
Responsible for gathering, maintaining and filing necessary and various supporting documents and reports to ensure that our E.P.A. products are registered and maintained in compliance with various State regulatory requirements.
Essential Duties and Responsibilities:
- Acts as company representative, developing and maintaining positive relationships with government agencies through oral and written communications.
- Review, register and maintain Market Labels for compliance with various regulations in relationship to product formulations.
- Maintains regulatory knowledge of EPA and State agency guidelines and regulations.
- Review and sign off on finished label artwork for compliance with various regulations.
- Provide support to consultants, category managers and internal departments.
- Responsible for filing the various annual, semi-annual and quarterly compliance documents to the appropriate state agencies.
- Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking documents submitted to both federal and state agencies.
- Participates in activities to create and improve regulatory processes and systems.
- Assists in developing procedures to ensure regulatory compliance.
- Assists in the development of regulatory metrics and project tracking.
- Serves as a member on manufacturing and development teams, providing regulatory feedback and guidance, and coordinating team inputs for submissions.
- Execute departmental policies and procedures
- Supports technical or business initiatives and special projects.
- Serves as an alternate company representative for all pesticide Federal registrations.
- Bachelors' degree required, in a scientific or technical discipline preferred: consideration may be given to those who hold 5+ years of progressively responsible and relevant work experience
- Minimum of 2 years’ experience in regulatory affairs field preferred.
- Ideal candidate will be familiar with EPA, CA Prop 65, and VOC Regulations.
Knowledge, Skills, and Abilities:
- Ability to read, analyze, comprehend and apply general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Excellent organizational abilities and communication skills.
- Must be proficient in Microsoft Operating platforms and associated Office suite programs that may include but not limited to Outlook, Word, Excel and Power Point.
- Must have above average spelling and grammar along with strong written and verbal communication skills.
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