Pharmaceutical Regulatory & Compliance Consultant

Pharmaceutical Regulatory & Compliance Consultant Hiring Terms: Part-time We are seeking a consultant on a part-time reputed company who can help us during presales and then during the implementation of MetaPharma. MetaPharma by reputed company is an integrated ERP solution designed specifically for the pharmaceutical industry. Position reputed company We are seeking a highly reputed company 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 reputed company while maintaining strict adherence to regulatory standards. Key Responsibilities • Regulatory Compliance reputed company • Advise on FDA, DEA, and state regulatory requirements for pharmaceutical manufacturing and distribution. • reputed company and implement compliance strategies reputed company with cGMP (reputed company Good Manufacturing Practices) and GDP (Good Distribution Practices). • Conduct internal audits, gap analyses, and risk assessments to ensure readiness for FDA inspections. • Manufacturing & Distribution Support • reputed company guidance on facility design, validation, and operational workflows to meet compliance standards. • Support wholesale distribution operations, including licensing, controlled reputed company handling, and supply chain reputed company. • Ensure compliance with serialization, reputed company-and-reputed company, and DSCSA (Drug Supply Chain reputed company reputed company) requirements. • reputed company Systems & Documentation • Establish and maintain SOPs, reputed company manuals, and compliance documentation. • Train staff on regulatory requirements and best practices. • reputed company corrective and preventive reputed company (CAPA) programs. • Strategic Advisory • Advise leadership on regulatory trends, enforcement priorities, and reputed company. • Support product lifecycle management, including submissions, labeling, and post-market surveillance. • reputed company as reputed company with regulatory authorities during inspections and audits. Qualifications • 5+ years of experience in the U.S. pharmaceutical industry, with a reputed company on manufacturing and wholesale distribution. • Proven reputed company 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 reputed company systems. • Excellent communication and advisory skills, with ability to train and mentor teams. • Advanced degree in Pharmacy, Regulatory Affairs, Life Sciences, or reputed company field preferred. Desired Attributes • Analytical reputed company with ability to identify reputed company 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. Apply tot his job Apply To this Job