Regulatory Affairs Associate

BPI Labs, a pharmaceutical manufacturing company based in Largo, FL, is seeking a Regulatory Affairs Associate, Licensing & Compliance to manage end-to-end licensing activities required for pharmaceutical manufacturing, distribution, and pharmacy operations. This role will focus on preparing, submitting, tracking, and maintaining licenses and permits with state and federal authorities, including Boards of Pharmacy, health departments, and the DEA. The position will work closely with Regulatory Affairs, Quality, Operations, and other internal stakeholders to ensure all licenses remain current and compliant.

Key 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 (Regulatory Affairs, Quality, Legal, Finance, HR, Operations) 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 in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related life science or healthcare discipline.
• Additional coursework or training in Regulatory Affairs, Healthcare Compliance, or Legal/Paralegal studies is a plus.
• Minimum 1–2 years of experience in Licensing, Compliance, or Quality roles within the pharmaceutical, healthcare, or other highly regulated industry.
• Experience with state licensing processes (e.g., Boards of Pharmacy, Department of Health) and/or DEA registrations is strongly preferred.
• 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, jurisdictions, and deadlines concurrently.
• Proficiency with Microsoft Office (Word, Excel, Outlook) and comfort working in document and tracking systems.
• Ability to interpret regulatory instructions and application guides and translate them into clear tasks and checklists.
• Professionalism, discretion, and ability to handle confidential and sensitive regulatory information.