Regulatory Affairs - Veterinary Clinical Project Associate

Eurofins PSS Insourcing Solutions; Kalamazoo (MI); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Comprehensive medical coverage

Dental and vision options

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

A global life sciences company in Kalamazoo, MI, is seeking to fill a full-time position in their Diagnostic Regulatory Team. The role involves preparing and facilitating the approval of veterinary diagnostic product labels for USDA licensing. Candidates need to have a Bachelor's degree and relevant product label experience. Strong communication, organizational skills, and attention to detail are essential. The position offers excellent full-time benefits, including medical coverage and a 401(k) plan.

Qualifications

• Prior product label experience.
• High level of competency using Microsoft Word and Excel.
• Ability to work independently while fostering good relationships.
• Strong verbal and written communication and organizational skills.
• High level of competency using Microsoft Office suite, Word, Excel and Adobe Acrobat.
• Ability to communicate in English with colleagues at all levels, attention to detail.

Responsibilities

• Liaise with teams for regulatory alignment and reviews.
• Generate new or revised editor's copies of labels.
• Ensure label compliance with USDA and global expectations.
• Generate editor's copies of labels for instruments and consumables.
• Utilize company systems for entry and tracking of regulatory activities.
• Manage and communicate accurate timelines for deliverables.

Skills

Strong verbal and written communication

Organizational skills

Attention to detail

Ability to communicate in English

Flexibility to handle multiple tasks

Teamwork

Education

Bachelor's degree in relevant discipline

Tools

SAP

Veeva Vault

Trackwise

Microsoft Office Suite

Adobe Acrobat

Adobe Acrobat

Job description

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 our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

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.

Job Duties

• 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.
• 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.

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