Regulatory Project Coordinator (In-Office Position)

Company 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

This position requires an understanding of pharmacovigilance practices with the responsibilities of applying this knowledge to assure regulatory compliance. This position contributes to regulatory activities focused on maintaining the pharmaceutical in-line portfolio for company animal health products. May also assist in the human health space. This position requires the ability to organize and compile the required information and documents for regulatory submissions, understanding of regulatory requirements and the ability to apply knowledge of regulatory requirements to support the Annual Drug Experience Reports submissions and Anti-Microbial report submissions. This position may contribute to special project work as assigned. This position requires interpersonal communication, database management and time management skills.

Responsibilities include but are not limited to:

• Prepares and submits adverse event cases for all company pharmaceutical products through E-Submitter or other approved databases.
•  Maintains a product review schedule
• Assists with preparation of Annual Drug Experience Reports and Anti-Microbial Reports for all company pharmaceutical products through E-Submitter or other approved databases.
•  Assists with database management (including running queries to assist with data quality, maintaining meeting minutes or setting agendas for internal project meetings)
• May contribute to special project work as assigned. 
• Proficiency in using Microsoft Office, including Outlook and Excel.

Qualifications

• Degree in biology, animal science or other related science.
• A minimum of 1 year of industry experience in the regulatory field OR in a quality assurance role with exposure to regulations from the FDA or other regulatory bodies. 
• Optional: Experience in pharmacovigilance adverse event submissions 

Additional Information

• Position is full-time, first shift.
• 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-LW1 

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.