Regulatory Affairs - Veterinary Clinical Project Associate

Eurofins • Kalamazoo, MI

17h

About The Position

As a member of the Diagnostic Regulatory Team, this position prepares and facilitates approval of editor’s copies of veterinary diagnostic product labels required for USDA licensing and global marketing authorization. Job Duties include, but are not limited to: Liaise with project teams, commercial colleagues, manufacturing, and in-country regulatory affairs managers to ensure alignment on content and subsequently thorough review of drafts to provide accurate editor’s copies to the company artwork center. Facilitate translation with external agency and review of translations by in country regulatory affairs managers. Utilize checklist and Outline of Production to ensure label compliance with USDA and global regulatory expectations. Generate new or revised editor’s copies of labels for veterinary diagnostic product instruments and consumables. As applicable, utilize company systems for entry and tracking of regulatory activities. Manage and communicate accurate timelines for deliverables.

Requirements

• Bachelor's in relevant discipline
• Prior product label experience.
• Strong verbal and written communication and organizational skills.
• High level of competency using Microsoft Office suite, Microsoft Word, Excel and Adobe Acrobat.
• Ability to effectively communicate in English with colleagues at all in various levels of the organization.
• Attention to detail to ensure all expectations for labels are met
• Flexibility and capacity to handle multiple tasks at once.
• Demonstration of highly effective teamwork, passion, "can-do" attitude, and enthusiasm
• Consistently models behaviors of accountability, approachability, and ownership.
• Ability to work independently, while fostering good working relationships across physical distance.
• Capability of supporting colleagues / teams in a multicultural, dynamic and constantly changing learning environment.
• Authorization to work in the United States indefinitely without restriction or sponsorship

Nice To Haves

• Knowledge of SAP, Veeva Vault and Trackwise preferred

Responsibilities

• Liaise with project teams, commercial colleagues, manufacturing, and in-country regulatory affairs managers to ensure alignment on content and subsequently thorough review of drafts to provide accurate editor’s copies to the company artwork center.
• Facilitate translation with external agency and review of translations by in country regulatory affairs managers.
• Utilize checklist and Outline of Production to ensure label compliance with USDA and global regulatory expectations.
• Generate new or revised editor’s copies of labels for veterinary diagnostic product instruments and consumables.
• As applicable, utilize company systems for entry and tracking of regulatory activities.
• Manage and communicate accurate timelines for deliverables.

Benefits

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level