Position Details
Regulatory Affairs Documentation Specialist Apply
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world, headquartered in Leverkusen, and areas of business include pharmaceuticals; consumer healthcare products, agricultural chemicals, seeds and biotechnology products.
Job Title: Regulatory Affairs/Documentation Specialist
Location: Saint Louis MI 63146
Duration: 6 Months
Job Type: Contract
Work Type: Hybrid
Job Description:
TASKS AND RESPONSIBILITIES:
- Support the team in the management of state regulatory activities necessary to obtain and maintain registrations including, FIFRA Sections 3, 24(c), 2(ee), 18, 5 for crop protection products;
- Communicate with State regulatory agencies regarding submissions, approvals, renewals and etc.
- Maintain and update regulatory databases and other internal tracking systems.
- Scan regulatory mail and other supporting documents, and file electronically.
- Track and Process payment of state registration fees, including but not limited to, new product registration fees, annual state renewal fees, tonnage and etc.
- Review product labels for accuracy and consistency.
- Maintain compliance by interpreting and evaluating federal and state registration requirements as they apply to our products;
- Provide regulatory support and service to both internal and external stakeholders;
- Respond to inquiries for regulatory information from internal and external stakeholders.
- Scan regulatory and supporting documents, file in databases and/or mail to designated recipients
- Other assignments, as required.
THE CANDIDATE IS REQUIRED TO POSSESS THE FOLLOWING:
- BA/BS in a field of science, business, or a related degree plus 2 years of professional working experience
- Strong attention to detail is required.
- Highly developed written and oral communication skills
- Proficiency in the Microsoft Office suite
- Database Management experience
- Strong problem solving skills
- Ability to multitask and manage multiple projects
- Ability to work independently and in a team environment
- Experience with document comparison tools is a plus.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
