Paralegal

Exela Pharma Sciences LLC; Lenoir (NC); On-site; USD 52,000 - 72,000; Full time

Job summary

Exela Pharma Sciences LLC is seeking a proactive Paralegal to support our Quality Assurance and regulatory compliance teams. The role focuses on contract management, vendor qualification, and ensuring FDA-aligned documentation supports daily operations.

The ideal candidate will bring at least 3 years of paralegal experience, a relevant certificate, and strong communication skills to collaborate with attorneys and cross-functional teams in a fast-paced pharma environment.

Qualifications

• At least 3 years of experience as a paralegal.
• Paralegal certificate or related degree required.
• Ability to handle highly confidential information with discretion.

Responsibilities

• Assist in drafting, reviewing, and maintaining Vendor Qualification documents and Quality Agreements.
• Support regulatory compliance efforts with FDA regulations and drug safety standards.
• Maintain and organize FDA compliance documents and records.
• Prepare task lists and execution timelines for regulatory compliance activities.
• Execute daily tasks with discipline and urgency to improve efficiency.

Skills

Organizational skills

Time-management

Written communication

Verbal communication

Independent work

Team collaboration

Microsoft Office

Legal document management systems

Proactive/adaptable

Education

Paralegal certificate

Tools

Microsoft Office Suite

Legal document management systems

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Paralegal

6 days ago Requisition ID: 2062

Position Summary

Exela Pharma Sciences is seeking a highly motivated, detail-oriented and assertive individual to join our fast-growing company in this non-traditional, yet highly fulfilling career track. The ideal candidate will support our attorneys in our Quality Assurance department in a variety of functions related to the pharmaceutical industry, including regulatory compliance, manufacturing operations, contract management, while driving efficiencies in executing daily tasks with a sense of urgency.

Job Responsibilities

• Contract Management: Assist in drafting, reviewing, and maintaining Vendor Qualification documents, Quality Agreements, and Audit Reports. Ensure all agreements are complete, unexpired, and compliant with company policies and FDA regulations.
• Regulatory Compliance: Support the legal team in ensuring that the company complies with all applicable pharmaceutical regulations, including FDA guidelines, drug safety laws, and pharmaceutical industry standards.
• Document Management: Maintain and organize FDA compliance documents and records, ensuring proper filing and compliance with retention policies.
• Prepare and Maintain Regulatory Compliance Activities Docket: Drawing on your paralegal experience, this activity involves preparing specific task lists and execution timelines and enforcing adherence to those timelines.
• Task Execution: Execute tasks in a disciplined and time-conscious manner to bring efficiency in daily tasks.

Experience Requirements

• At least 3 years of experience as a paralegal. No experience in the pharma industry is needed.
• Experience in a compliance-driven industry (banking, pharma, automotive, etc) is a plus.
• Strong organizational and time-management skills, attention to detail and accuracy are must.
• Excellent written and verbal communication with assertiveness.
• Ability to work independently and as part of a team.
• Proficient in Microsoft Office Suite and legal document management systems.
• Ability to handle highly confidential information with discretion and professionalism. A proactive attitude with a willingness to learn and adapt to a fast-paced environment.

Education Requirements

• Paralegal certificate or a related degree from an accredited institution.