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Regulatory Affairs Specialist (Entry)

TekWissen LLC

Chesterfield, MO(remote)

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JOB DETAILS
SALARY
$34.50–$34.50
SKILLS
Agriculture, Biotech and Pharmaceutical, Communication Skills, Data Management, Database Administration, Database Management Software/Systems (DBMS), Detail Oriented, Diversity, Healthcare, Maintain Compliance, Microsoft Office, Multitasking, Payment Processing, Presentation/Verbal Skills, Problem Solving Skills, Product Reviews, Project/Program Management, Query Analysis, Regulations, Regulatory Submissions, Standard Operating Procedures (SOP), State Laws and Regulations, Team Player, Workforce Management, Writing Skills
LOCATION
Chesterfield, MO(remote)
POSTED
2 days ago
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 Specialist (Entry)
Location: Chesterfield,MO 63017
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Remote
Job Description:
  • When reviewing candidates for this role, I am particularly interested in individuals whose professional experience extends beyond a traditional laboratory environment focused solely on following established SOPs (Standard Operating Procedures).
  • This position operates in a highly dynamic and evolving environment, requiring flexibility, adaptability, and the ability to manage changing priorities.
  • Therefore, I look for candidates who can demonstrate experience working in settings where they were required to think critically, solve problems independently, manage multiple priorities, and adapt to new challenges rather than simply executing predefined processes.
  • It doesn't have to be extensive experience, but these are the type of things that gives me insight into a candidate's fit.
  • Additionally, I value candidates who have experience working with databases or data management systems.
  • This experience may include entering, maintaining, querying, analyzing, or managing information within a database.
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.

About the Company

T

TekWissen LLC

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.



COMPANY SIZE
100 to 499 employees
INDUSTRY
Computer/IT Services
FOUNDED
2009
WEBSITE
http://www.tekwissen.com/

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