Regulatory Affairs Associate Scientist - Labeling

Job Description

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.

• 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.

Qualifications

• Bachelor's in relevant discipline
• Prior product label experience.
• Knowledge of SAP, Veeva Vault and Trackwise preferred
• 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.

Additional Information

• 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