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Regulatory Affairs Scientist

2 months ago

Niles, Illinois, United States Jacobs Management Group Full time
Job Overview

We are seeking a **Regulatory Affairs Scientist** to play a pivotal role in a dynamic pharmaceutical organization. This company is dedicated to delivering high-quality branded and generic medications, medical devices, and nutraceutical products. In this position, you will significantly shape the regulatory and compliance framework, ensuring strict adherence to FDA regulations, which is vital for the health and safety of patients.

Why Consider This Opportunity:

  • Be at the forefront of pharmaceutical compliance initiatives.
  • Utilize your knowledge of FDA regulations and guidelines.
  • Attractive salary along with a comprehensive benefits package.
  • Access to medical benefits, educational support, and retirement plans.
  • Potential for career advancement within a growing organization.
  • Collaborate with a supportive and focused team.

Key Responsibilities:

  • Review and monitor FDA applications to ensure compliance.
  • Conduct audits of suppliers and contract manufacturing organizations to verify adherence to GMP and FDA standards.
  • Design and implement strategies to improve regulatory submissions.
  • Establish routine audit processes and compliance monitoring reports.
  • Work closely with senior leadership on regulatory compliance issues.

Candidate Profile:

  • Ability to fulfill the responsibilities outlined.
  • Expertise in regulatory compliance within the pharmaceutical sector.
  • Experience with ANDA/510K submissions and supplier audits.
  • Strong analytical and problem-solving skills.
  • Excellent organizational and communication capabilities.
  • In-depth knowledge of GMP/GLP/cGMP standards and analytical methodologies.

This role offers a unique opportunity to contribute to the regulatory landscape of a leading pharmaceutical company.