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Regulatory Compliance Specialist

2 months ago

Camarillo, California, United States Actalent Full time
Job Description

**Regulatory Compliance Specialist**

We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Actalent. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and ensuring the quality and integrity of our products.

Key Responsibilities:

  • Regulatory Compliance: Ensure compliance with regulatory requirements, including FDA regulations, DEA regulations, and other relevant laws and regulations.
  • Product Labeling: Develop and maintain accurate and compliant product labeling, including Structured Product Labeling (SPL) and other regulatory documents.
  • Regulatory Reporting: Prepare and submit required regulatory reports, including GDUFA, Establishment Registration, and SPL Annual Certification.
  • Dea Arcos Reporting: Maintain data on controlled substances and prepare and submit quarterly and annual DEA Arcos submissions.
  • Licensing and Registration: Maintain current knowledge of licensing and registration requirements and ensure compliance with all relevant agencies.
  • Regulatory Affairs: Participate in and provide support to other regulatory affairs and compliance activities as needed.

Requirements:

  • Education: Bachelor's degree or 5 years or more of pharmaceutical regulatory experience required.
  • Skills: Regulatory compliance, FDA registrations, regulatory affairs, medical device, regulatory documents, biology, GMP, biotech, quality assurance, FDA, certificates, product labeling, licensing, reporting, ISO 13485, FDA certification, quality, quality systems, QMS, eQMS, GMP auditing, EH&S safety, audit.

About Actalent:

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market.