Global Regulatory Affairs Associate
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Job Location:
Kalamazoo, MI - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 departments 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 clients quality systems and equipment.
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
Yes
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
About Company
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
