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Regulatory And Compliance Specialist

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Actalent

14d ago

  • Job
    Full-time
    Mid & Senior Level
  • Legal
  • Camarillo

AI generated summary

  • You must assess new products, manage NDC assignments, ensure compliance with labeling regulations, report adverse events, maintain licenses, and communicate with regulatory bodies effectively.
  • You will assess new products, manage NDC assignments, maintain compliance databases, prepare reports, and interact with regulatory bodies while ensuring adherence to regulations and SOPs.

Requirements

  • The Regulatory and Compliance Specialist is responsible for initial new product assessment, confirming authorized distributors, NDC assignment, Structured Product Labeling (SPL’s), DEA Arcos Reporting, DEA Class II Quota, FDA registrations, Licensing and reporting.
  • Responsible for maintaining an accurate database of the status of all NDC’s currently assigned and assign new NDC’s as necessary.
  • Own new product review process to include manufacturer, and product approval, SPL required information, PPE requirements, required cleaning validation rating, hazardous waste impact and safety concerns.
  • Ensure receipt of current authorized distributor of record (ADR) certificates from all product suppliers.
  • Prepare Structured Product Labeling (SPL) for new products and communicate cross functionally of posted SPL’s.
  • Review ongoing product labeling to ensure compliance.
  • Maintain current knowledge of current SPL related regulations and requirements and communicate same to appropriate stakeholders.
  • Responsible for electronically reporting all potential FAERS adverse events.
  • Prepares and submits all required FDA and regulatory reports including: GDUFA, Establishment Registration and SPL Annual Certification.
  • Responsible for maintaining data on all controlled substances as required for quarterly and annual DEA Arcos submissions.
  • Prepare and submit DEA Form 106 for potentially lost/stolen controlled products.
  • Completes and submits data required for the U.S. Dept. of Commerce Census Report.
  • Monitor/renew state licenses (Wholesale/Manufacture/Controlled) as required.
  • Identify modifications for all required licenses and/or registrations in order to maintain corporate compliance with all pertinent agencies.
  • Prepare Foreign Corporation Registration and annual report submissions for each required state.
  • Responds to and interfaces with Regulatory Body as required.
  • Participates in, and provides support as needed to other regulatory affairs, regulatory compliance activities as the relate to the department and the company as a whole.
  • Read, understand and abide by written instructions and SOPs.

Responsibilities

  • The Regulatory and Compliance Specialist is responsible for initial new product assessment, confirming authorized distributors, NDC assignment, Structured Product Labeling (SPL’s), DEA Arcos Reporting, DEA Class II Quota, FDA registrations, Licensing and reporting.
  • Responsible for maintaining an accurate database of the status of all NDC’s currently assigned and assign new NDC’s as necessary.
  • Own new product review process to include manufacturer, and product approval, SPL required information, PPE requirements, required cleaning validation rating, hazardous waste impact and safety concerns.
  • Ensure receipt of current authorized distributor of record (ADR) certificates from all product suppliers.
  • Prepare Structured Product Labeling (SPL) for new products and communicate cross functionally of posted SPL’s.
  • Review ongoing product labeling to ensure compliance.
  • Maintain current knowledge of current SPL related regulations and requirements and communicate same to appropriate stakeholders.
  • Responsible for electronically reporting all potential FAERS adverse events.
  • Prepares and submits all required FDA and regulatory reports including: GDUFA, Establishment Registration and SPL Annual Certification.
  • Responsible for maintaining data on all controlled substances as required for quarterly and annual DEA Arcos submissions.
  • Prepare and submit DEA Form 106 for potentially lost/stolen controlled products.
  • Completes and submits data required for the U.S. Dept. of Commerce Census Report.
  • Monitor/renew state licenses (Wholesale/Manufacture/Controlled) as required.
  • Identify modifications for all required licenses and/or registrations in order to maintain corporate compliance with all pertinent agencies.
  • Prepare Foreign Corporation Registration and annual report submissions for each required state.
  • Responds to and interfaces with Regulatory Body as required.
  • Participates in, and provides support as needed to other regulatory affairs, regulatory compliance activities as the relate to the department and the company as a whole.
  • Read, understand and abide by written instructions and SOPs.

FAQs

What is the primary responsibility of a Regulatory and Compliance Specialist?

The primary responsibility is to oversee initial new product assessments, confirm authorized distributors, manage NDC assignments, and ensure compliance with regulatory requirements, including Structured Product Labeling, DEA reporting, and FDA registrations.

What qualifications are typically required for this position?

The role generally requires an intermediate level of experience in regulatory affairs, compliance, or a related field, along with knowledge of relevant regulations and requirements.

What types of reports will I be responsible for preparing and submitting?

You will be responsible for preparing and submitting various FDA and regulatory reports, including GDUFA, Establishment Registration, SPL Annual Certification, and the U.S. Dept. of Commerce Census Report.

Will I need to interact with regulatory bodies?

Yes, you will be required to respond to and interface with regulatory bodies as needed.

Are there specific training or certifications that would be beneficial for this role?

While not explicitly required, certifications in regulatory affairs or compliance, along with training on FDA regulations and controlled substances, would be beneficial for this position.

Is this position eligible for hybrid or remote work?

Yes, this position supports a hybrid work format, allowing for a combination of remote and in-office work.

What additional responsibilities does this role include aside from regulatory compliance?

Additional responsibilities include maintaining current knowledge of regulations, monitoring and renewing state licenses, and providing support for other regulatory affairs and compliance activities.

How does the company support diversity and inclusion in the workplace?

The company is committed to diversity and inclusion through hiring diverse talent, maintaining an inclusive environment, promoting a culture of care and recognition, and providing growth opportunities for all employees.

What is the process for managing controlled substances in this role?

You will be responsible for maintaining data on controlled substances for quarterly and annual DEA Arcos submissions, as well as preparing and submitting DEA Form 106 for potentially lost or stolen controlled products.

Are there opportunities for growth within this position?

Yes, there are opportunities for growth as the company emphasizes career development and providing growth opportunities for its employees.

Actalent

An Engineering and Sciences Services Company | People to Possible

Human Resources
Industry
5001-10,000
Employees

Mission & Purpose

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent’s global footprint and flexible delivery models ensure access to specialized talent where and when you need it. We promote consultant engagement through professional development and provide experiences to ensure continuous learning. Our people are the difference. Our expertise spans capabilities in engineering including product and manufacturing, systems and software, construction management, environmental, architecture and civil; and power and utilities. We focus on sciences capabilities in laboratory sciences, healthcare, and clinical research. Actalent is an operating company of Allegis Group, the global leader in talent solutions.