Pharmaceutical Regulatory & Compliance Consultant jobs in United States
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MetaOption LLC ยท 2 days ago

Pharmaceutical Regulatory & Compliance Consultant

positionUnited States
timeFull-time
remoteRemote
senioritySenior Level
date5+ years exp

MetaOption LLC is seeking a highly experienced Pharmaceutical Regulatory & Compliance Consultant to assist during presales and implementation of their integrated ERP solution for the pharmaceutical industry. The role involves ensuring compliance with U.S. FDA regulations and providing guidance on manufacturing and distribution operations.

Cloud ComputingCRMEnterprise Resource Planning (ERP)Information TechnologyIT InfrastructureSaaSSoftware

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

Qualification

FDA regulatory complianceCGMPGDPDSCSAPharmaceutical manufacturingWholesale distributionDEA complianceQuality systemsAnalytical mindsetCommunicationStrategic thinker

Required

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

Preferred

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

Company

MetaOption LLC

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Global Information Technology Company in New Jersey, USA.
dateFounded in 2005
location
Jersey City, New Jersey, USA
people-size51-200 employees
web-link
http://www.metaoption.com

Funding

Current Stage
Growth Stage

Leadership Team

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Naushad Ahmed
CEO
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Company data provided by crunchbase