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Regulatory Affairs Specialist

2 months ago

Louisville, United States TEKsystems Full time

Description:

Internal Regulatory Processes Management:

  • Coordinate and Document: Manage, coordinate, and document internal regulatory processes. This includes activities such as inspections, internal audits, license renewals, and registrations.
  • Government Approval: Assist in obtaining and maintaining government approval for materials like drugs, medical devices, and nutritional products.

Materials Preparation and Submission:

  • Collect and Compile: Gather and compile materials needed for registration and submission to regulatory agencies.
  • Materials Review: Review product promotional materials, labeling, batch records, specification sheets, and test methods for compliance with applicable regulations and policies.

Cross-Functional Collaboration:

  • Interdepartmental Coordination: Work across multiple departments to ensure effective coordination of tasks related to regulatory affairs.
  • Strategic Balancing: Achieve a balance between regulatory concerns, marketing objectives, time-to-market, technology, compliance, and costs.

Product Development Expertise:

  • Comprehensive Understanding: Understand all aspects of product development, including clinical trials, research, manufacturing practices, and approval processes.
  • Advisory Role: Advise project teams on export and labeling requirements, premarket regulatory needs, and clinical study compliance.

Skills and Attributes:

  • Effective Communication: Ability to communicate effectively in a demanding environment.
  • Interpersonal Skills: Collaborate with cross-functional teams.
  • Regulatory Knowledge: Stay updated on evolving regulations worldwide.

Additional Skills & Qualifications:

  • Bachelor’s degree in a relevant field (e.g., life sciences, pharmacy, or related disciplines).
  • 3 Years Experience in regulatory affairs within biotechnology, pharmaceuticals, or medical device companies.
  • Familiarity with product development processes and regulatory requirements.

We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following:

  • Medical, Dental & Vision
  • 401(k)/Roth
  • Basic/Supplemental Life & AD&D
  • Short and long-term disability
  • HSA & DCFSA
  • Transportation benefits
  • Employee Assistance Program
  • Company Paid Time off or State Sick Leave
About TEKsystems:

We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.