Pharmaceutical Regulatory & Compliance Consultant

MetaOption, LLC•Jersey City, NJ

About The Position

We are seeking a consultant on a part-time basis who can help us during presales and then during the implementation of MetaPharma. MetaPharma by MetaOption LLC is an integrated ERP solution designed specifically for the pharmaceutical industry. Position Overview We are seeking a highly experienced Pharmaceutical Regulatory & Compliance Consultant with deep expertise in U.S. FDA regulations, DEA requirements, and state-level compliance frameworks. The ideal candidate will have extensive experience in pharmaceutical manufacturing and wholesale distribution, ensuring operational excellence while maintaining strict adherence to regulatory standards.

Requirements

5+ years of experience in the U.S. pharmaceutical industry, with a focus on manufacturing and wholesale distribution.
Proven track record in FDA regulatory compliance, including cGMP, GDP, and DSCSA.
Experience working with controlled substances and DEA compliance.
Strong knowledge of pharmaceutical supply chain operations and quality systems.
Excellent communication and advisory skills, with ability to train and mentor teams.

Nice To Haves

Advanced degree in Pharmacy, Regulatory Affairs, Life Sciences, or related field preferred.
Analytical mindset with ability to identify compliance risks and propose practical solutions.
Hands-on experience with audits, inspections, and remediation.
Strategic thinker who can balance regulatory requirements with business objectives.
Ability to work independently as a consultant and collaborate effectively with cross-functional teams.

Responsibilities

Advise on FDA, DEA, and state regulatory requirements for pharmaceutical manufacturing and distribution.
Develop and implement compliance strategies aligned with cGMP (Current Good Manufacturing Practices) and GDP (Good Distribution Practices).
Conduct internal audits, gap analyses, and risk assessments to ensure readiness for FDA inspections.
Provide guidance on facility design, validation, and operational workflows to meet compliance standards.
Support wholesale distribution operations, including licensing, controlled substance handling, and supply chain integrity.
Ensure compliance with serialization, track-and-trace, and DSCSA (Drug Supply Chain Security Act) requirements.
Establish and maintain SOPs, quality manuals, and compliance documentation.
Train staff on regulatory requirements and best practices.
Oversee corrective and preventive action (CAPA) programs.
Advise leadership on regulatory trends, enforcement priorities, and compliance risks.
Support product lifecycle management, including submissions, labeling, and post-market surveillance.
Act as liaison with regulatory authorities during inspections and audits.