Regulatory Affairs Associate - 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.
We have an opening at our Charlottesville, VA, facility for a Regulatory Affairs Associate whose role will be to:
* Develop and maintain product labeling in compliance with laws and regulations.
* Execute regulatory labeling activities to ensure that the established project plan due dates for milestones are met.
* Contact Regulatory Agencies or outside consultants to resolve regulatory labeling issues.
* Process change requests in compliance with internal SOPs and related regulations.
* Maintain regulatory files and data systems in compliance with internal SOPs.
* Represent regulatory affairs in project meetings.
* Gather, analyze and summarize technical and research information and regulatory updates. Present information to department members, verbally and in writing, to ensure department members are informed promptly.
* Prepare and maintain project plans; work with department members to monitor progress and identify any barriers to project completion.
The ideal candidate will have the following skills, and education:
* Must possess analytical skills and the ability to identify and apply policies and general regulations to specific products or projects.
* Ability to monitor, analyze, raise awareness, and assess impact of regulatory issues with support of Supervisor.
* Good verbal and written communication skills are necessary.
* The ability to participate on project teams is required.
* Basic knowledge of scientific, regulatory, and legal terminology is necessary.
* 1-2 years working experience.
* Bachelor degree required. Bachelor degree in a health sciences field preferred. Experience in the health care or food industry preferred. Experience in regulatory affairs preferred.