Global Regulatory Affairs Associate

Consider joining Lancaster Laboratories where people are the most important element in our chemistry. Celebrating 50 years of service, Lancaster Laboratories is a leading contract lab providing testing and research services in the environmental, pharmaceutical, and biopharmaceutical sciences to clients worldwide.

Job Description

Eurofins PSS is lookin for a new member for our team to help working with preparation of publication submissions and document management!

This role will help with following:

• Prepare submissions in eSubmitter or relevant Agency web-based systems.
• Provide electronic document importing support and archiving for VMRD.
• Upload electronic documents and respective metadata into Veeva Vault. Review documents to ensure submission quality.
• Perform page merge/extractions using PDF and zip files.
• Perform and complete document Information checks for documents signed within Veeva Vault.
• Assist as necessary with ordering, securing, and archiving Literature References for regulatory submissions.

Qualifications

Candidate will need to possess the skills:

• E-submitter experience preferred or related web-based agency submission system. Substantial working knowledge and experience with electronic document management systems in a regulatory corporate setting. Expertise with Microsoft Word, Excel, and Adobe Acrobat.
• Assist with the assembly and document sourcing in support with Agency (FDA, EPA) submissions (e.g. A&P, NCIEs, CMC).
• Assemble and submit regulated Agency documents, to tight deadlines and high-quality standards, using the department’s submission publishing systems.
• Adhere to the appropriate use of the submission publishing and document management systems, through use of working practices such that regulatory compliance is preserved.
• Work with the submission publishing team to ensure that all assigned submission requirements and timelines are mutually understood and in line with corporate standards and deadlines for submission delivery.

Minimum

Qualifications

• Authorization to work in the United States indefinitely without restriction or sponsorship
• Bachelors or Masters Degree in Biological or Chemical Science.

Additional Information

What we offer:

• 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
• Career Development and continuing education opportunitie

Position is full-time, 8am - 5pm with occasional overtime required.

Eurofins Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients’ site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.

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