Regulatory Affairs Veterinary Clinical Project Associate

Kalamazoo, MI - USA

Monthly Salary: Not Disclosed

Posted on: 3 days ago

Vacancies: 1 Vacancy

Job Summary

As a member of the Diagnostic Regulatory Team this position prepares and facilitates approval of editors 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 editors 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 editors 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 :

Bachelors 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.
Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information :

Position is full-time Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Kalamazoo MI are encouraged to apply.
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

#LI-EB1

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

Employment Type :

Full-time

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 editors 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 editors 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 :

Bachelors 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.
Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information :

Position is full-time Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Kalamazoo MI are encouraged to apply.
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

#LI-EB1

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

Employment Type :

Full-time

Key Skills

Proofreading
Adobe Acrobat
FDA Regulations
Manufacturing & Controls
Biotechnology
Clinical Trials
Research & Development
GLP
cGMP
Product Development
Chemistry
Writing Skills

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About Company

Eurofins

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more

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