[Remote] Pharmaceutical Regulatory & Compliance Consultant

Note: The job is a remote job and is open to candidates in USA. 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. 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 Skills • 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 • 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 Overview • Global Information Technology Company in New Jersey, USA. It was founded in 2005, and is headquartered in Jersey City, New Jersey, USA, with a workforce of 51-200 employees. Its website is Apply tot his job