Paralegal - Licensing & Regulatory Compliance

Job Overview

We are seeking a detail‑oriented Paralegal to manage end‑to‑end licensing and related regulatory support activities. The role will focus on preparing, submitting, tracking, and maintaining licenses and permits required for pharmaceutical manufacturing, distribution, pharmacy/503B outsourcing, DEA‑related activities, and other statutory approvals as needed by the company.

This position will work closely with Executive Management, Operations, Quality, Regulatory Affairs, and external agencies to ensure that all licenses remain current, compliant, and aligned with applicable federal and state requirements.

Responsibilities

• Prepare, submit, and track applications for state pharmaceutical manufacturing and distribution licenses across multiple US states.
• Coordinate and maintain pharmacy and 503B outsourcing facility licenses, including initial applications, renewals, and amendments.
• Assist with DEA registrations, modifications, and renewals, and maintain supporting documentation and records.
• Monitor license status, key dates, and renewal deadlines; maintain an accurate licensing calendar and proactively initiate renewal processes.
• Compile, organize, and verify required documentation (corporate, regulatory, quality, facility, ownership, etc.) for license submissions.
• Draft and edit forms, cover letters, attestations, and responses to information requests from state boards of pharmacy, health departments, and other authorities.
• Liaise with state and federal agencies, respond to routine inquiries, and follow up to resolve application issues or delays.
• Maintain organized electronic and physical files for all licenses, permits, and related correspondence.
• Coordinate with internal stakeholders (Operations, Quality, Legal, Finance, HR, Regulatory Affairs) to gather information needed for applications and renewals.
• Track and summarize regulatory or procedural changes impacting licensing requirements and flag them to management.
• Support internal and external audits/inspections by providing accurate and up‑to‑date licensing documentation.
• Prepare routine licensing status reports and metrics for management.

Qualifications

• Bachelor’s degree preferred, ideally in Paralegal Studies, Legal Studies, Healthcare Administration, Regulatory Affairs, or a related field.
• Paralegal certificate from an accredited program strongly preferred (or equivalent relevant experience in a paralegal/compliance role).
• Minimum 2–3 years of experience as a Paralegal, Licensing Specialist, or similar role.
• Prior experience with licensing in healthcare, pharmaceuticals, medical devices, or other highly regulated industries strongly preferred.
• Experience interacting with state boards (e.g., Boards of Pharmacy) or similar regulatory bodies is a plus.
• Familiarity with DEA registrations or controlled substance regulatory requirements is beneficial.
• Strong attention to detail and accuracy in handling forms, dates, and documentation.
• Excellent written and verbal communication skills for interacting with agencies and internal teams.
• Strong organizational and time‑management skills, with the ability to manage multiple applications and deadlines concurrently.
• Proficiency with Microsoft Office (Word, Excel, Outlook) and comfort working in document management or tracking systems.
• Ability to interpret instructions, application guides, and regulatory requirements and translate them into clear tasks.
• Professionalism, discretion, and ability to handle sensitive company and regulatory information.